Transcript Title: Helvetica Bold 24
Slide 1
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 2
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 3
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 4
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 5
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 6
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 7
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 8
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 9
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 10
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 11
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 12
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 13
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 14
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 15
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 16
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 17
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 18
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 19
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 20
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 21
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 22
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 23
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 24
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 25
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 26
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 27
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 28
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 29
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 2
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 3
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 4
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 5
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 6
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 7
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 8
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 9
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 10
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 11
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 12
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 13
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 14
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 15
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 16
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 17
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 18
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 19
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 20
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 21
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 22
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 23
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 24
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 25
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 26
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 27
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 28
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
•
Questions?
© 2015 Akana., Inc. All Rights Reserved.
Slide 29
MDR Implementation:
Drivers & Challenges
Julie Smiley
Director, Product Management for BioPharma
Akana
PhUSE SDE - May 14, 2015
© 2015 Akana., Inc. All Rights Reserved.
Agenda
•
•
•
•
Overview
Drivers for Metadata Management Solution
Procurement & Implementation Challenges
Keys to Success
© 2015 Akana., Inc. All Rights Reserved.
Survey Overview
“Research shows that content is growing by as much as 200% per year, and
the risks of not managing it effectively are growing even faster.” (ASG)
•
•
Survey conducted at CDISC Interchange US 2013 & EU 2014
Goal to understand the following:
– Where industry is in terms of standards/metadata management (MM)
– What is driving industry in this direction
– What challenges they face in procuring/implementing a solution
•
Survey participants: 75+ globally, from 55 different organizations
© 2015 Akana., Inc. All Rights Reserved.
Participants by Organization Type
1%
7%
5%
5%
Consulting & Technology
14%
CRO
1%
3%
Device
Other
Pharma
Regulatory Agency
64%
Research Institute
Technical provider
© 2015 Akana., Inc. All Rights Reserved.
MM Projects by Company Size
16
14
12
10
Yes
No
8
Unk
6
4
2
0
<10k
© 2015 Akana., Inc. All Rights Reserved.
10-50k
50-100k
>100k
Project Stage
Production
21%
Planning
48%
Implementation
14%
Development
14%
© 2015 Akana., Inc. All Rights Reserved.
Assessment
3%
Satisfied with Current Solution
Unknown
Research
Consultant
DM
Yes
Stat Programming
No
Biostat
IT
Standards & Governance
0
© 2015 Akana., Inc. All Rights Reserved.
2
4
6
8
10
12
Reasons for Dissatisfaction
• Top 3 Answers
– Unstable, Outdated, or Inefficient
– CDISC Compliance
– Version Control
• Other Answers
–
–
–
–
–
Governance Support
Study Metadata Management
Not Global
Glossary Management
IT Support
© 2015 Akana., Inc. All Rights Reserved.
DRIVERS FOR METADATA
MANAGEMENT SOLUTION
© 2015 Akana., Inc. All Rights Reserved.
Driver selection
• Based on literature and experience
–
–
–
–
–
–
–
Regulatory Compliance
Data Quality
Business Process Efficiency
Data Exchange
Interoperability
Risk Management
Cost Savings
• ‘Other’ category added
© 2015 Akana., Inc. All Rights Reserved.
Drivers Most Chosen
83%
Data Quality
67%
Regulatory Compliance
64%
Business Process Efficiency
59%
Data Exchange
58%
Interoperability
Risk Management
Cost Savings
© 2015 Akana., Inc. All Rights Reserved.
47%
46%
Europe/Asia Drivers Chosen
83%
Data Quality
Business Process Efficiency
71%
Interoperability
71%
67%
Data Exchange
63%
Regulatory Compliance
54%
Risk Management
50%
Cost Savings
0%
© 2015 Akana., Inc. All Rights Reserved.
10%
20%
30%
40%
50%
60%
70%
80%
90%
Driver Ranking by Percent of Responders
90
80
70
60
50
40
30
20
10
0
Not ranked
© 2015 Akana., Inc. All Rights Reserved.
7
6
5
4
3
2
1
Drivers by Company Size
80
70
60
50
40
30
20
10
0
Large (>50K employees)
Medium (10-50K employees)
Small (<10K employees)
© 2015 Akana., Inc. All Rights Reserved.
Driver Changes by MM Project
No MDR Project
Existing MDR project
0%
Data Quality
Business Process Efficiency
Data Exchange
© 2015 Akana., Inc. All Rights Reserved.
50%
100%
Regulatory Compliance
Interoperability
Risk Management
Driver Changes Throughout MM Project
40
35
30
25
20
15
10
5
0
Not answered
In production
Development
Assessment
© 2015 Akana., Inc. All Rights Reserved.
How MDR Can Facilitate Drivers
•
•
•
•
•
•
•
•
Regulatory compliance with clear traceability from source to submission and
standards compliance
Data quality via controlled metamodel, validations, and decreased need for
human review and interpretation
Study artifact production from standards
Business process automation to augment/replace manual processing
Interoperability by tying data to standards and semantics
Data exchange through integrations, semantics interoperability, and
standardized exchange formats
Risk management via industry semantics and terminology use, data quality,
compliance, and business process efficiency
Cost savings through process automation
© 2015 Akana., Inc. All Rights Reserved.
MDR PROCUREMENT &
IMPLEMENTATION
CHALLENGES
© 2015 Akana., Inc. All Rights Reserved.
Overall Challenges
Business Process Change
Information Silos
Budget Constraints
Mergers & Acquisitions
Other
0
© 2015 Akana., Inc. All Rights Reserved.
10
20
30
40
50
60
70
Perceived vs. Actual Challenges
No MDR
Project
MDR Project
0%
© 2015 Akana., Inc. All Rights Reserved.
20%
40%
60%
80%
100%
Implementation Challenges
80
70
60
50
40
30
20
10
In production
0
Development
Business
Process
Change
© 2015 Akana., Inc. All Rights Reserved.
Information
Silos
Budget
Constraints
Assessment
Mergers &
Acquisitions
Other
Challenges - Beyond the Metrics
•
•
•
•
Organizational change management
Trying to take on too much at once
Training and skillsets
Managing external factors/changes (regulations,
acquisitions/mergers, standards, etc.)
• Roles & responsibility changes
© 2015 Akana., Inc. All Rights Reserved.
Key recommendations for procuring a solution and key
requirements
KEYS TO SUCCESS
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations
•
•
Develop a long-term vision for your organization
Clearly understand existing business processes
–
–
–
–
–
–
–
•
What is the process
Who are the stakeholders
What are the handoffs
What works well in current processes
Where is there room for improvement
What are the input artifacts to each process
What artifacts result from each process
Have a core project team to drive the project forward
– Project Manager
– Architect and/or business analyst
– Management support (e.g., steering committee)
© 2015 Akana., Inc. All Rights Reserved.
Pre-Implementation Recommendations (2)
•
•
•
•
Ensure Sr. Leadership support and ownership of project
Document requirements, even if only at high level (e.g., current business
case and future business case)
Use a process for vendor evaluation/selection
Document high level implementation goals
– Scope
– Timelines
•
Clearly scope implementation phases/releases:
– Small enough to roll out releases quickly to the business
– Large enough to see real benefit
– Examples:
• R1 – get standards in system and governance processes established
• R2 – study level metadata implementation across priority functions
• R3 – increase constraints, processing, automation, and add more business functions
•
If not already existing, establish governance organization
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations
•
•
•
Secure budget up front, but expect ongoing re-justification
Strong business sponsorship
Dedicated IT & business project manager(s)
–
–
–
–
–
–
–
–
–
Manage timelines, budget, and project resources
Ensures ongoing buy-in from the business
Primary contact with vendor(s)
Organizes meetings
Documents meeting minutes
Ensures action items are carried through
Works through any contract details
Keeps project on track
Oversees the business change management
© 2015 Akana., Inc. All Rights Reserved.
Implementation Recommendations (2)
• Small, agile core team
–
–
–
–
–
–
–
Clearly allocated time to project
Knows the business and project well
Can bring in appropriate resources as needed
Has the ability/authority to make decisions
Works through assessment with vendor
Writes test scripts & organizes system testing
Works on new process documentation, SOPs, policies, training
materials, etc.
• Do not underestimate the size of the project
• Do not rely to heavily on consultants/vendors
© 2015 Akana., Inc. All Rights Reserved.
Key Solution Requirements
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Flexible model for consistent management of metadata
Configurable governance processes
CDISC standards compliance (current and future)
Support for multiple standards levels and study level metadata
Reporting/metrics capabilities
Version management
Validation of metadata
Business process automation
Traceability of data throughout its lifecycle
Integration capabilities
Role-based user access
Ability to notify users of work assignments
Import/export capabilities
Web-based UI
© 2015 Akana., Inc. All Rights Reserved.
Q&A
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Questions?
© 2015 Akana., Inc. All Rights Reserved.