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Jason Housley Associate Director, Data Management / Infrastructure, Shire

English Speaking User Group The ‘Metadatacentric’ approach – End to End demonstration and discussion. Jason Housley Associate Director, Data Management / Infrastructure, Shire. Special Thanks…. To SAS for hosting this event. The traditional process. Gaps / challanges.

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Jason Housley Associate Director, Data Management / Infrastructure, Shire

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  1. English Speaking User GroupThe ‘Metadatacentric’ approach – End to End demonstration and discussion Jason Housley Associate Director, Data Management / Infrastructure, Shire

  2. Special Thanks…. • To SAS for hosting this event

  3. The traditional process

  4. Gaps / challanges Protocols are manually generated – inconsistent. Protocol templates do not dovetail with end in mind (SDTM terminology for example) Manually generated thus error prone / takes time on critical path Interpretation / transcription errors in configuration a risk Transposition specs manually written, non-standard and not machine executable Rapid data availability can be an issue especially in outsourced models. Adaptive design response issues. Non specific protocols – ‘We’re going to perform some tests on some stuff at some point’ As manually configured and interpreted – Error prone, increases time on critical path From non-machine executable .doc (RAP) – risk of interpretation error Testing takes time on critical path From non-machine executable .doc (SAP) – risk of interpretation error

  5. The outsourcing conundrum Sponsor CRO Interpretation issues further exacerbated

  6. Future opportunities

  7. How might that look in an outsourced scenario?

  8. Future State - summary • Standards underpin process improvement. • Machine executable metadata is key to automation.

  9. High Level Benefits • CDISC business case (PhRMA-Gartner-CDISC) report projects: • ~60% of the non-subject participation time • ~80% savings in the start-up stage

  10. Making it real……. Over to: Philippe Verplancke – XClinical Andrew Newbigging – Medidata Douglas Bain – Medidata Mark Wheeldon – Formedix David Smith – SAS

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