UTILIZING CDISC STANDARDS TO DRIVE EFFICIENCIES WITH OPENCLINICA Mark Wheeldon CEO, Formedix Boston June 21, 2013

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1 UTILIZING CDISC STANDARDS TO DRIVE EFFICIENCIES WITH OPENCLINICA Mark Wheeldon CEO, Formedix Boston June 21, 2013

2 AGENDA Introduction Real World Uses : Saving Time & Money. Your Clinical Trials Automated. Everywhere CDISC : A Quick Primer Perfect Libraries Perfect Study Set-up Study Build Automation Dataset Automation Conclusions

3 INTRODUCTION Vendor neutral using CDISC since 2000 Optimize End-to-End Clinical Trial Process Formedix Origin - Universal Design Tools Data Acquisition Design & Dataset Design Origin Study and Submission Modeller Formedix Transform - Universal Execution EDC, epro, IVRS and ETL multi platform & multi vendor OpenClinica, DataLabs, InForm,PRISM, Rave, TrialMaster & Paper Create one library work with all. Train in one work in all Formedix Consult Consultancy Services Planning, preparation, implementation, multi-edc execution Data Standards Director has won 2 awards from CDISC

4 REAL WORLD USES SAVING TIME & MONEY

5 FORMEDIX SAVES TIME & MONEY Libraries Content Reuse - 70% reuse - Standards maintenance resources down by 23% - Just this use case ROI 8 months Study Set-up - Specification auto-generation - Boston Scientific proved a 68% reduction - With CROs, Partners, EDC vendors. Study Build - Automate EDC build build - 55% reduction in EDC build Study Conduct and Analysis - 76% reduction in transformations

6 YOUR CLINICAL TRIALS. AUTOMATED. EVERYWHERE.

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8 YOUR CLINICAL TRIALS AUTOMATED. EVERYWHERE.

9 YOUR CLINICAL TRIALS AUTOMATED. EVERYWHERE. Libraries Study Set-up - Dynamic creation of All Study Specifications For all Roles For all Systems Study Build - Automated build of Multiple Platforms - EDC, epro, IVRS and ETL Study Conduct and Analysis - Automated validation Submission - Define.pdf, Annotated CRFs & Submission-Ready CRFs

10 CDISC : A QUICK PRIMER

11 CDISC & EXTERNAL STANDARDS STREAMLINING THE END-TO-END TRIAL Core Models Building Blocks & Containers - Protocol, ODM, SDTM, ADaM, Define.xml Common to all Content Standards - SDTM Implementation Guide and CDASH Controlled Terminology (CT) - NCI - CT-SDTM, CT-CDASH, CT-QS, CT-ADaM, CT-SEND Therapeutic Area Standards - CDISC, FDA, NCI & TransCelerate - Pain, Virology, Tuberculosis etc. Semantics - BRIDG

12 WHAT IS CDASH ODM?

13 PERFECT LIBRARIES FOR OPENCLINICA

14 itunes METASTORE THE MULTIMEDIA END-TO-END STORE METADATA STORE itunes is a trademark of Apple Inc. Achieving the itunes of Clinical Trials is an independent presentation/publication and has not been authorised, sponsored or otherwise approved by Apple Inc. Music CONTROLLED TERMS Apps TV Shows CONTROLLED Books TERMS ORIGIN METASTORE Movies Tones ORIGIN METASTORE Podcasts

15 LIBRARIES REDUCE DESIGN EFFORT &TIME

16 ORIGIN METASTORE & CDISC PERFECT RE-USE EVERYWHERE. Quality is built in up-front not tested in CDISC Libraries/Metadata Repositories - Vendor neutral and portable Re-use of all study design components - Across end-to-end clinical trial - Across multiple platforms - Across multiple vendors & systems Design once - Only test new content or changed content - Standardized CRFs, datasets and mappings

17 BIG PHARMA GREAT CONTENT NEEDED A MODEL Standards were stored in many formats - Word, Excel, Oracle, SAS,.pdf, etc. CDISC ODM = one human & machine readable format Converters were developed Inconsistencies and errors revealed ODM was extended to support business needs Custom validators for content compliance Big Pharma now have a re-usable & portable library - 18,000+ fields Expect enormous efficiency gains in - DM study set-up, working with CROs, downstream with datasets

18 LILLY MAKES THE ODM LIBRARY PUBLIC lillyodmlibrary.codeplex.com

19 OTHERS ARE GIVING AWAY CONTENT MEDICAL DATA MODELS

20 HOW DO YOU GET THERE?

21 Content in CDISC Models SDTM Annotation Mapped Datasets Multi-Platform Readiness Libraries

22 PERFECT STUDY SET-UP

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24 STUDY START-UP SPECIFICATION 24

25 MULTIPLE SPECIFICATIONS AUTOGENERATED

26 STUDY BUILD AUTOMATION

27 TRANSFORM FOR OPENCLINICA Leverage CDISC - Set of extensions to CDISC - Supports OpenClinica proprietary features Custom Exporter - Export as converts CDISC to OpenClinica metadata OpenClinica Visualization - See OpenClinica screens as you build with CDISC - Very sophisticated could be active OpenClinica Validator - Checks CDISC - Checks invalid OpenClinica designs

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29 AUTOMATED MULTI-PLATFORM & SYSTEM BUILD

30 MULTI-VENDOR ecrfs AUTOGENERATED

31 METRICS SCORECARD HOW CAN WE IMPROVE

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33 MYTH OF ODM RAISING THE INTEGRATION BAR CDISC ODM does not support - Calculations, conditions and complex edit checks - It does - methods, conditions and formal expressions ODM Certification - 29% of ODM metadata CDISC certification passed Transform Integration Coverage - Coverage charts will be published - Transform will automate 80-90% of entire EDC build New Possibilities - Universal edit check spec across platforms/vendors - Universal edit check execution - execute everywhere Partnership Transform for OpenClinica

34 OPTIMIZING STUDY CONDUCT

35 PRODUCTION STUDY CONDUCT 35

36 TWO IMPLEMENTATIONS: THE BEST END-TO-END WITH ODM Libraries in ODM Mapping Library Libraries in Define MAPPING LIBRARY Data Capture Data Populated ODM CDISC Datasets

37 TWO IMPLEMENTATIONS: THE BEST END-TO-END WITH ODM Libraries in ODM Mapping Libraries Libraries in Define PROP. EDC A PROP. EDC B EDC A EDC B PROP. EDC C PROP. EDC D EDC C EDC D Data Capture Proprietary Export Dataset CDISC Datasets

38 CONCLUSION Libraries - Portable, vendor neutral non-proprietary format - Reuse everywhere end-to-end & in multiple systems & platforms - 70% reuse Study Set-up - Proven 68% time savings Study Build - Proven 55% reduction in EDC build Study Conduct and Analysis - Proven 76% reduction Highly scalable end-to-end process

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