Learn how PAREXEL's Clinical Metadata Repository can help improve the way you manage clinical trial data.

1. © 2017 PAREXEL INTERNATIONAL CORP.
SEAMLESS
DATAFLOW WITH
A CLINICAL
METADATA
REPOSITORY
September 27th 2017, La Jolla, CA
Julius Kusserow

2. © 2017 PAREXEL INTERNATIONAL CORP. / 2
AGENDA
• Problems we observe
• Hub & spoke model – to
connect the data
• Study instance metadata – to
have a machine readable
protocol
• The metadata repository
(MDR) – to bring it all together
• Having all together - Benefits
for using the PAREXEL
Clinical MDR to Manage
Metadata on Studies

3. © 2017 PAREXEL INTERNATIONAL CORP. / 3
ABOUT PAREXEL
• A leading global
biopharmaceutical services
organization
• 30+ years assisting clients in
pharmaceutical, biotechnology,
and medical device industries
• We are physicians,
technologists, business process
experts,
and more
WE ARE A TEAM OF EXPERTS
DEDICATED TO YOUR JOURNEY
TO MARKET.

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WHAT WE OFFER
PAREXEL is focused on end-to-end integrated solutions – from
product strategy and clinical development through market access
and lifecycle management.
We simplify the journey between science and new treatments by applying:
BEST MINDS PROBLEM-SOLVINGINNOVATION

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PROBLEM 1: DIFFERENT INTERPRETATIONS OF THE
SAME PROTOCOL
• Different interpretations of
protocol
• Need for data reconciliation
• Time to build integrated
SDTM data sets, ADaM &
TLFs

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PROBLEM 2: LINEAR BUILD - “WALKING THE LINE“
We work in a linear way… with circles
ANALYZE
Tabulation data needs to be available before the analysis
datasets are created
Comment
TABULATE
Data needs to be entered before we can produce tabulation
data (SDTM)
Wait
Comment
BUILD
We need to build a database before we can enter data
Wait

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PROBLEM 3: MISALIGNMENT OF STUDIES TO
STANDARDS
Standard
Study 1 Study 2 Study 3≠ ≠
• Studies follow standard on a structure level, but diverge on the
implementation of variable content which could lead to different
semantics.
• Harmonization costs additional time.

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HUB AND SPOKES
LIFECYCLE
MANAGEMENT
OFDATA
STANDARDS
LIBRARYOF
SIM
STUDY INSTANCE
METADATA
PAREXELCLINICALMDR
Same things in the real world are represented by a concept.
The pattern allows a logical association between:
• one Domain Definition Variable in the Hub, representing a concept
• and different Spoke Variables, representing different expressions of the concept

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… IN AN EXAMPLE
• Mapping by declaration to
concepts
• Allows End to End (E2E) data flow
dry-run without data
• Study teams worry about the what
not the how
• ISO 21090 BASED
CLINICAL RECOGNIZABLE
CONCEPTS
• DATA IS MAPPED TO AND
FROM A HUB
• USABLE FOR CDISC AND
OTHER DATA MODELS
(HUB)
CDASH / Data Collection
AESEV Severity
SDTM / Data Tabulation
AESEV Severity/Intensity
(SPOKES)
AE Domain Definition
Pattern Ordinal Coded Item
Concept SEV Severity/Intensity
ADaM / Data Analysis
AESEV Severity/Intensity
AESEVN Severity/Intensity (N)
ASEV Analysis Severity/Intensity
ASEVN Analysis Severity/Intensity (N)
SEVGRy Pooled Severity Group y
SEVGRyN Pooled Severity Group y (N)

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…IN THE FUTURE
LIFECYCLE
MANAGEMENT
OFDATA
STANDARDS
LIBRARYOF
SIM
STUDY INSTANCE
METADATA
PAREXELCLINICALMDR
The pattern can be extended (if needed) to allow a logical association of already defined
Domain Definition Variables to new Spokes

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STUDY INSTANCE METADATA - THE MACHINE READABLE
PROTOCOL
Common Process
• Different interpretations of protocol
• Need for data reconciliation
• Time to build integrated SDTM
data sets, ADaM & TLFs
3 Tier approach with MDR & SCE
• One single interpretation of protocol
• Increased consistency and data quality
• Reduced time for integration

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MANAGEMENT OF
DATA STANDARDS
THE METADATA REPOSITORY
PAREXELCLINICALMDR
HUB & SPOKES
EDC
IVRS
ePRO
Lab
Macro Library
Statistical Computing
Environment
Data Surveillance
Protocol Optimization
Clinical Data Repository
MANAGEMENT OF
STUDY INSTANCE
METADATA
Study Design
(SDTM TDM)
Visit Schedule
with T&E
HUB & SPOKES

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• Hub and spokes
model bridged all
cracks between the
different department
standards
• Development of
concepts and pattern
is a cross functional
effort
The MDR is necessary
to:
• Maintain all the
metadata on a
standard level
• Give study team the
tools to handle the
metadata
• Study teams see
impact on down the
line activities during
planning
• Study Instance
Metadata (SIM)
brought study
execution closer to
standards
governance
DATA
BRINGING IT ALL TOGETHER
TECHNOLOGYORGANIZATION
PAREXEL CLINICAL MDR
Enabling MDR Technology
Underpinning by Hub, Spokes, Concepts & Pattern
Aligned Governance Processes

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• Each setup along the line
is aware of upstream &
downstream impact.
• Concepts allow to focus
on the content and avoid
common traps.
• Study related standards
governance reduced
• Metadata driven mapping
• Better setup
• Ability to have mappings
earlier
BENEFITS
QUALITY EFFORTSTUDY
TIMELINES

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THANK YOU
© 2017 PAREXEL INTERNATIONAL CORP. / 15