Transcript Second Quarter 2006 Financial Results Conference Call

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Vertex and CDISC
Accomplishments and Strategy
12 March 2008
Lynn Anderson
Associate Director
Statistical Programming/Biometrics
Pam Ryley, Associate Director
Scott Moseley, Senior Director
Vertex and CDISC / MBC / 12March2008
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Vertex and CDISC - Overview
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SDTM, ADAM (and CDASH)
• Operations and Submissions
• In-House and Out-Source
• Business Processes and Quality
Architecture
• Technology and Tools
Vertex and CDISC / MBC / 12March2008
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Vertex and CDISC - Overview
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• CDASH – Clinical Data Acquisition
Standards - FUTURE
• SDTM – Study Data Tabulation
Model
• ADAM – Analysis Dataset Model
Vertex and CDISC / MBC / 12March2008
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Vertex- CDISC – 2008 Goals - 50,000 ft
Operations
Submissions
 SDTM 
ADAM
 SDTM
 SDTM &
ADAM 
TFLs
 SDTM
loaded into
WebSDM
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ADAM
Annotated eCRF
SDTM
Define.xml
Includes trial design
and define.xml
Raw Data
(If possible, close to SDTM/CDASH)
 ADAM
 ADAM and
Key Tables
Programs
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CDASH - 5,000 ft
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1. Take CDASH into account when building clinical
database
• Extracted ‘raw’ data is standardized for
‘easy’ transformation into the SDTM model
• Enabled by standardized eCRFs
• Applies to external data sources also (either
integrated into the clinical database or not)
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SDTM and ADAM - 5,000 ft
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SDTM datasets
• Specification – automation drives datasets
development, review, and submission metadata
• Development – (In-House) SDLC – automation
• Review – WebSDM plus outside WebSDM
• Use for data review
• Use for developing ADAM datasets
• Use for analysis (with ADAM datasets)
• Submit to regulatory agency
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SDTM and ADAM - 5,000 ft
Extract
Raw Data
Build DB
CDASH
eCRF
Clinical
Database
Submit:
•Annotated eCRFs
•SDTM Datasets
•ADAM Datasets
•TFL’s
•Metadata (define)
Vertex and CDISC / MBC / 12March2008
Transform To
SDTM
CDASH
Study
Data
Analysis
(TFL’s)
SDTM
Study
Data
ADAM
Study
Data
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SDTM Datasets Specification– 500 ft
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CDISC Master Domains Metadata Template
(Enhanced with Vertex domains, columns, suppqual
standards, and mapping logic)
Plus
CDISC Controlled Terminology Template
Are Customized
and Then Drive
•
Specification of Conversion of Raw data into SDTM
format
•
Development of SDTM Datasets from Raw Data
•
Review of SDTM Datasets for correctness against the
standard and against the raw data
•
Submission Metadata
Vertex and CDISC / MBC / 12March2008
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SDTM Datasets Specification– 500 ft
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CDISC
Master
Domains
Workbook
PLUS
CDISC
Master
Terminology
Workbook
PLUS
Part 1
General
SDTM
Specification
Part 2
Study
Specific
SDTM
Specification
WriteSpec.SAS
CDISC_spec
SAS Macro
Part 3 Detailed
SDTM
Specification
Put pieces together
into one document
Vertex
CDISC
SDTM
Specificatio
n
Vertex and CDISC / MBC / 12March2008
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SDTM Datasets Development – 500 ft
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• Independent QC is incorporated into
development whether in-house or
outsource
• At Vertex this is an automation in
progress – mapping and logic columns
in the specification driver workbook
also drive macro programming to
create these datasets
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Review of SDTM Datasets – 500 ft
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• Review plan talks about strategy for review –
this will differ between when we are
outsourcing (more extensive) versus when we
are developing datasets in-house (since tools
in this case are validated and trusted by us)
• Use of WebSDM in this process gives added
benefit of providing a single repository for our
clinical trials data – AND gives an opportunity
to conduct WebSDM-style safety review on
single and pooled studies
Vertex and CDISC / MBC / 12March2008
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Review of SDTM Datasets With WebSDM
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Specify CDISC
SDTM Datasets
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Develop Review
Plan for CDISC
SDTM Datasets
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Develop CDISC
SDTM Datasets
No
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Receive
Datasets
5
Preprocess
Datasets
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Create
Directories in
Load Area
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Create
Application
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Create Study
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Copy Datasets
to Load Area
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Load datasets
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Successful
Load?
Yes
No
12
Review SDTM
Errors
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Download
SDTM Errors
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Assign Error
Details to SDTM
Errors
Augment 15
Checks in
Accordance
with Review
Plan
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Feedback to
SDTM
Dataset
Developers
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Datasets
Ready
for Review?
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Yes
18
Data Review
Accept
Datasets?
No
Yes
20
Assign Error
Details to
SDTM Errors
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Accept
Datasets
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Create ADAM datasets from SDTM
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5. Develop ADAM datasets from SDTM
datasets (and Protocol/SAP of course)
6. Develop TFL’s from SDTM and ADAM
(Programming specifications)
7. Submission: SDTMs, SDTM annotated CRF,
define.xml, ADAMs, TFLs, Key Programs
for ADAMs and Tables
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Out-Source versus In-House
We want a single set of logical and consistent
processes (supported by thorough repetitive
training) but where does outsource versus inhouse present a challenge?
•
•
•
•
Anything about CDASH
Development of SDTM Datasets
Review of SDTM Datasets
Other
Vertex and CDISC / MBC / 12March2008
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SOP and Working Instruction Framework
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• We are committed to develop & maintain a quality
and business process framework that makes
sense.
• While CDISC adoption is a unique effort from TFL’s
production and FDR support and FDA submissions,
we need these activities to all reference the same
Systems Development Lifecycle
• Inversely, we need our Vertex Statistical
Programming Systems Development Lifecycle to
support all our departmental responsibilities
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SOP and Working Instruction Framework
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Definition of Departments
Biometrics = Biostats and Stat Programming
Software/System
Development Life
Cycle (SDLC)
SAPS
TFLs
Interims
Submissions
Blinding
Quality
Vertex and CDISC / MBC / 12March2008
CDASH
SDTMs
WI’s
Specification
of SDTM
SDTM Review
ADAMs
WebSDM App &
Study Config
Macro
Library
Dev
WebSDM App &
Study Config
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Future Directions
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• Standardize processes more: revisit, improve
• Automate processes more: specification, raw data
transformation to SDTM, more data review tools
based on SDTM, create ADAMs, create metadata
(define)
• Integrate processes and tools across the larger
process more tightly
• Timings: create SDTM (including Trial Design) and
define.xml earlier
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Future Directions
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• Extend training and distribute the CDISC
understanding and tasks
• Continue improving quality framework – processes
that are supported sufficiently by official
documentation and that are clear and work across
outsource scenarios
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