1 / 11

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.

kbolinger
Download Presentation

Jason Housley Associate Director, Data Management / Infrastructure, Shire

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related