ODM The Operational Efficiency Model: Using ODM to Deliver Proven Cost and Time Savings in Study Set-up

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2 ODM The Operational Efficiency Model: Using ODM to Deliver Proven Cost and Time Savings in Study Set-up Mark Wheeldon, CEO, Formedix Bay Area User Group Meeting, 15 th July 2010

3 Who are we? Proven Business Benefits of ODM What is ODM? End to End Clinical Trial Process with CDISC ODM in Study Start-up Libraries Study Design/Specification CDMS/EDC Build Automation Conclusions Agenda

4 Introduction to Formedix Background Involved with CDISC Standards since 2000 CDISC Software Products Formedix Origin - first ODM and define.xml study design tools Formedix Transform - EDC and paper integration products Formedix Submit data transformation engine Must Work with Existing Processes and Tools CDISC Consultancy Services Planning, preparation and implementation Cross trained in all the CDISC metadata & data models Technical Director won 2 awards from ODM team Optimize Study Design & Downstream Data Conversions

5 Libraries Content Reuse 20-80% re-use Standards maintenance decreased resources by 23% Just this use case Lilly ROI 8 months Study Design/Specification Boston Scientific 68% reduction With CROs, partners, EDC vendors. Build Automation Integration to automate EDC system build 40-60% reduction in study build Downstream Data Transformations 76% reduction Where CDISC ODM Saves Time & Money

6 What is the ODM? Overview The ODM is a model that describes the content and structure of a CRF or database Two sections Metadata design of CRF or database Data snapshot and transactional ODM data is hierarchical and arranged around subjects Best Practice ODM Modelling Balance data entry ease vs. downstream transformations Get it wrong here pay the price later!! A lot of the metadata in the ODM ends up in the SDTM Look at an annotated CRF Category, position etc.

7 ODM End to End Uses Libraries Study Specification Dynamic Creation of Study Specifications For all Roles For all Systems Build Automated build of EDC/CDMS Testing As specified vs. As built Downstream Replacement for datasets Easiest way to get to SDTM

8 Overview of End to End Powered by CDISC <ODM> <Study> <Meta </Meta </Study> </ODM> Reuse

9 Libraries of Reusable Study Designs Re-usable Study Database Design Content Use CDISC Database Metadata - ODM Vendor neutral Machine readable = No more Excel Suitable for any target system Paper, EDC 1, 2, CRO A,B Libraries of study events, forms, items, codelists Combine with content standards Common to all forms = CDASH library in ODM Therapeutic specific forms = ODM library with internal standards

10 Practical Experience Lilly Data Element Standards in ODM Lilly standards were stored in many formats Word, Excel, Oracle, SAS,.pdf, etc. Converters - proprietary formats to ODM Lilly now have a reusable library 15,000+ fields Lilly expect enormous efficiency gains in DM study set-up Working with CROs Downstream activities in Stats Think big; start small; grow fast.

11 Lilly is Making the ODM Library Public lillyodmlibrary.codeplex.com 46 th Annual Meeting Washington, DC

12 What is a CDASH-ODM Form Composed Of? <ODM> <Study> <Meta </Meta </Study> </ODM>

13 How could you Implement Libraries Today?

14 Standards Enabled Libraries Further Reduce Design Effort and Time Task Study Breakdown* Before Standards % Reuse With Standards % Reuse Common to All Forms 29% 0% 100% (AE,CM, etc) Therapeutic Specific 71% 0% 20% - 80% *Metrics from Genzyme MACI Study

15 Genzyme s Study Set-up Process Before CDISC Standards Manual production of detailed study design docs No standard CRFs or clinical data elements No design metadata reuse across EDC systems Multiple templates/formats & different vendor styles Labor-intensive cross functional authoring Protracted review / approval process Documents are not role specific Late availability of relevant review materials No standard metadata change control process Many reviewers/approvers = more review/approval cycles Multi-discipline reviews Internal reviewers / External reviewers EDC epro CRO 15

16 Multi-system Multi-vendors Pre-Standards

17 Multi-vendor Study Specification Before ODM CRF anddatabase Design Documentation Minimal Content Reuse Manually Create EDC System Design Protocol Available Interpret into Database Design Manually Create Event- Form Matrix Manually Create Annotated CRFs Manually Create CRFs/ EDC ecrf Layout

18 Metrics for an ODM Driven Design Review - Approval Process Task CRF/Database Design Review and Approval Before Standards With Standards Time Reduction % Reduction 300hrs 110hrs 190hrs 63% 48hrs 12hrs 36hrs 75% Total - 1 study 492hrs 158hrs 334hrs 68% Metrics measured and kindly supplied by

19 Require no knowledge of the CDISC or XML Drag and Drop Libraries CDISC Study Design Tools Key Requirements Reuse from past studies and content standards (CDASH) Visualizations Role centric CRFs, tabular database specifications Multi-vendor view Paper, EDC, epro Extension Technology Easy extend the standard Represent proprietary features of any target system Paper, EDC and epro

20 No more hand building of this <ItemDef DataType="integer" Length="8" Name="Body System" OID="MHBODSYS" Origin="CRF" SASFieldName="MHBODSYS"> <Question> <TranslatedText>Body System</TranslatedText> </Question> <CodeListRef CodeListOID="CL_MHSYSTEM"/> </ItemDef> <ItemDef DataType="text" Length="80" Name="MH Abnormality" OID="MHTERM" Origin="CRF" SASFieldName="MHTERM" SDSVarName="MHTERM"> <Question> <TranslatedText>Abnormality</TranslatedText> </Question> </ItemDef>

21 A Dedicated Authoring Environment for Each Standard Origin Study Modeller Origin Submission Modeller

22 Preview as you build - Visualizations Tabular Database Specification Clinician/Monitor Centric ecrf/paper Form

23 Role Centric Visualizations Clinician s ecrf

24 Role Centric Visualizations Data Manager s Tabular Specification

25 Multi-Vendor Visualizations PhaseForward

26 Multi-Vendor Visualizations Nextrials

27 Multi-Vendor Visualizations - Medidata

28 Multi-Vendor Visualizations - Paper

29 Customizing the ODM is Simple Presentation Business Rules Library Admin Version number Endless Anything e.g. extensions for CTMS/EHR One ODM: Many views Generic View Inform View

30 Automated Study Design, Build and Test Process with CDISC ODM Reuse EDC/Paper Set-up Complete Fewer Review- Approval Cycles Manual Database Build Build Process Manual Test of Database Build Test Process

31 Optimal Study Design Process

32 Outsourcing with ODM & Define.xml New Opportunities Strategy One Give CRO your library they produce specifications Take library system/vendor neutral implementation Go with CRO preferred EDC solution/paper Strategy Two Specify study in house using library Give CRO human readable specifications Give CRO ODM or proprietary metadata derived from ODM QC Track changes As built vs. as specified Study vs. Master Standards library all automated

33 Track Changes During Design or Mid Study

34 As Specified vs. As Built or Study vs. Master Library

35 Incorporating Study Changes into a Master Standards Library

36 End to End Clinical Trial Process Before CDISC

37 End to End Clinical Trial Process With Standards

38 Metadata management solutions Portable, vendor neutral non-proprietary format Facilitating re-use in studies and across systems Efficiencies in study set-up Conclusions CDISC ODM Delivers Proven 68% time savings Auto generation of specifications from CDISC ODM Efficiencies in downstream system set-up Proven 40-80% reduction in EDC build times Proven 76% reduction in data transformation times Highly scalable end to end clinical trial process

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