Transcript Zimmer Biostatistics and Clinical Data Management (BCDM) Noah Sheeley April 10,2014 11/7/2015 1 Zimmer Profile Zimmer is one of the largest orthopedic companies in the.

Zimmer Biostatistics and Clinical
Data Management (BCDM)
Noah Sheeley
April 10,2014
11/7/2015 1
Zimmer Profile
Zimmer is one of the largest orthopedic companies in the world
with top worldwide market share in both hip and knee implants.
 Zimmer employs nearly 9000 employees and has offices all over the
world with 130,000 products being sold in over 100 countries,
reaching worldwide annual sales of $4.6 billion in 2013.
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Clinical Trials
Zimmer has 130,000 different products.
We are conducting clinical trials with hundreds of doctors at
dozens of sites around the world. These studies must meet the
requirements of the many regulatory bodies around the
world including the FDA.
Currently our department the BCDM group has:
 35 regulated projects (IDE studies, PMCFs)
 85 non-regulated projects (pilot studies, lab studies)
 15 publication studies
Human
Tissue
Cups and
Stems
Knees
Hip
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Business Problem
Before: Check every field on every form
Error: Mail the form back to the site
Start
 Site mails the correction back to us
 Check Every field on every form
Complete
CRFs
Ship
CRFs
Review
CRFs
Data Entry
CRFs
Errors?
File Copy
CRFs
Investigate
CRFs
Errors?
File
CRFs
Current Process <= 3 Weeks
Review
Data
Investigate
CRFs
Errors?
Investigate
CRFs
Process
Complete
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Additional Business Problems
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Multi Page forms with over 100 Data Elements
Complex Calculations, Validations, Lists, etc.
Must be HIPAA Compliant & Secure
Must be FDA compliant out of the box
On-Line / Off-Line Issues
Self-Administration Required
Poor Legibility on Paper Forms creates:
 Financial Liabilities
 Potential for Medical Errors
 Incomplete Medical Record
 Statistical Analysis Errors
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Key Decision Factors/Business Case
 Enter Data while it is being Collected
 Pre-Fill Form with:
 Pick Lists (Meds, Devices, etc.)
 Data from Previous Visit (Patient History)
 Calculations
 Enforce Accuracy with Real-Time Validations
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Business Case
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Highly-Skilled, Highly-Paid, Time-Constrained
Surgeons & Physicians
Spending 2 to 4 desk hours per shift
Completing Medical Record & Billing Sheets
Need to Cut Data Collection Time by >= 50%
Without Sacrificing Accuracy or Acceptance
Time Savings, Billing, and Compliance
Estimated $1K to $2K Savings per Day
+ Happier Surgeons
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Business Case
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Produce cost-justified increases in data collection
speed and accuracy
Implement a software and hardware infrastructure as
reliable as the current paper-based system
Deploy a system meeting the requirements of the current
information technology infrastructure
Comply with HIPAA security requirements
Employ a data input interface capable of transcribing verbal
observations to written data inputs
Provide an intuitive interface and workflow gaining
end-user acceptance by examiners and clinicians
Allow multiple, doctor’s sites to participate
Satisfy all FDA 21 CFR Part 11 regulations and internal data
quality monitoring requirements
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Value Proposition
“The one thing I can’t give
my faculty is more time.
The Optiform solution offers
the opportunity to more
effectively capture data
and manage the care plan while
decreasing the time investment.”
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Benefits Realized
Start
Paper Process <= 3 Weeks
Complete
CRFs
Ship
CRFs
MiCo Process <= 72 Hours
Review
CRFs
Data Entry
CRFs
Review
Data
Errors?
File Copy
CRFs
Investigate
CRFs
Errors?
File
CRFs
Investigate
CRFs
Errors?
Investigate
CRFs
Process
Complete
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Benefits Realized
 In 2013, using MiCo we collected data for 5 FDA regulated
studies and 24 Post Market Clinical Follow-ups
 This was around 45,000 CRFs
 Paper – .8 min per CRF to process the data & any
discrepancies/DCFs eClinical – .1 min per CRF submitted
 This is a nearly 90% reduction in discrepancy management.
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Benefits Realized
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Increased quality of care by providing more treatment
time with patients as result of more efficient access to
and collection of patient data.
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Increased data quality by eliminating poor legibility of
paper-based Progress Notes with the system’s on-the-fly,
ink-to-text, recognition.
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Prevention of medical record and/or billing errors by
enforcing real-time validation of data.
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Reduced data collection time by pre-filling Progress Note
form fields with previous patient data, complex
calculations, test results, medication lists, and treatment
data.
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Benefits Realized
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Maximization of billing revenue by calculating diagnosis
(ICD9) and billing codes without human intervention.
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Elimination of the manual upkeep of a billing sheet log by
automatically transferring Progress Note data to billing
reports.
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Bypass of the tedious paper capture by transferring
digital ink forms directly to the electronic medical record
(EMR).
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Enhanced instructional experience by providing
Attending Physicians with a simultaneous view of the
Progress Note being presented by Residents
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Mi-Forms Tablet PC Benefits
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The speed of data collection has decreased
from 3 weeks to less than 72 hours
There have been far fewer rejections of data sets
resulting in a much higher data quality rate
Fewer trips to data collection sites for
site monitoring tasks have been required
Resolving inconsistencies in submitted data requires less time due to
a shorter time interval between collection and detection
The time required to file and organize
case report forms has been eliminated
The cost of printing and distributing
paper forms has been virtually eliminated
End-user training and acceptance has been positive
The operation and battery life of the Tablet PCs
have been remarkably reliable
Electronic submissions between remote sites
and the central site has been extremely stable
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Mi-Forms Tablet PC Benefits
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“We have been very pleased with the speed and accuracy
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“The data just shows up in the database”
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“The dental device manufacturer has been equally pleased
with the speed and accuracy of the data collection process”
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“Ready for prime time!”
of data collection that the new eCRF solution has provided”
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Demonstration
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Summary –
Business Lessons Learned
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2 page form = 1,000 hours of development
Lock-Down the SOW
Use Solution Implementation Sign-Offs
Do Weekly Status Reports / Change Orders
Data Dictionary is Key Component
Engage with IT Dept Early (don’t be fooled)
Keep your Champion Happy
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Lessons Learned
Document/Deliverable
Components
Testing
1. Tablet & eCRF
2. Server IQ & Mi-Forms
Installation
Validation Plan
3. Download & Upload to
Mi-Forms Server, security
4. IQ SQL Database, Idera
System Architecture Drawing
software
Risk Assessment
Requirements
(user requirements –
what software does,
what hardware is
needed)
Software Vendor
Qualification
5. SQL Database – transfer from
Mi-Forms, accessibility, audit trail
6. Export data from SQL Database
& import into SAS
Tablet & eCRFs
Mi-Forms Server v6
Traceability Matrix
Create
SQL Database
Security Plan
Technology Environment
SAS Dataset
Data Management & Staff Access
Optiform Vendor Evaluation
Backup/Recovery/Retention
Data Protection
Design
Tablet & eCRFs
Mi-Forms Server & Designer
SQL Database
SAS Design
Summary Report
Create
Business Continuity Plan
(Contingency Plan)
Create
User Training SOP for the
Tablet PC and/or Server
Create
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Optiform Profile
HQ in Indianapolis
 Focus on Healthcare
 Develop “Best-of-Breed” Component Solutions for
Clinical Data Collection Apps
 Many Customers using Paper-Based Recognition
Technologies (i.e. OCR/ICR)
 Increasingly Difficult to gain Maximum Efficiencies
with Paper-Based Technologies
 Using Mi-Forms where Pain & Cost are High
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Question & Answer
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