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End-to-End Study Management using BRIDG

End-to-End Study Management using BRIDG. Peter Smilansky Head of Consulting Practice, HCL Life Sciences Jonathan Stieglitz Senior Business Architect Consulting Practice, HCL Life Sciences Jian Chen President, EDETEK, Inc.

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End-to-End Study Management using BRIDG

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  1. End-to-End Study Management using BRIDG Peter Smilansky Head of Consulting Practice, HCL Life Sciences Jonathan Stieglitz Senior Business Architect Consulting Practice, HCL Life Sciences Jian Chen President, EDETEK, Inc.

  2. BRIDG - Biomedical Research Integrated Domain Group Model • The BRIDG Model is an information model, representing a shared view of the concepts of protocol-driven clinical research. This structured information model is being used to support development of data interchange standards and technology solutions within the biomedical/clinical research arena and between research and the healthcare arena. • BRIDG is a platform for expressing the processes and data concepts of clinical research in a consistent manner across all the stakeholders • Stakeholders include CDISC, FDA, NCI and HL7 • Open development model – anyone can contribute • BRIDG is the vehicle to harmonize existing CDISC standards (SHARE) • BRIDG persistence can physically store all Clinical Research Data BRIDG Overview

  3. Why BRIDG? News: BRIDG CDR Relational Structure Exists!

  4. BRIDG – Bridging Clinical Research and Health Care

  5. Managing Study using BRIDG

  6. Step 1 : Create Common Libraries – eCRF & TLF BRIDG Defined Activities • eCRF: • Common Activities • Associated Forms • BRIDG Mappings BRIDG Defined Activities • TLFs • Common Endpoints • Reporting Templates • BRIDG Mappings BRIDG Mapping BRIDG Mapping 7

  7. Step 2 : Study Development - Protocol Study Protocol Versions are developed, and are associated with Defined Activities

  8. Step 3a : Study Design – Data Collection • Define Arms • Define Epochs • Define Segments • Define Cells • Define Study Events • Define Workflow Study Design Model (SDM)

  9. Study 3a : Generate eCRF eCRF Design eCRF Designer EDC EDC

  10. Step 3b : Study Design - Analysis

  11. Study 3c : Study Design - Reporting

  12. Step 3c : Study Design - Monitoring

  13. Step 4 : Study Initiation and Subject Enrollment • Study Initiation • Instantiate Study Activities • Site Initiation • Instantiate Study Site • Subject Enrollment • Instantiate Study Subject • Instantiate Scheduled Activities Planned Activity Scheduled Activity

  14. Step 5 : Study Conduct

  15. Step 5 : Creation of BRIDG Data Auto-Generated based on Library and Study Design

  16. Step 5 : From BRIDG to Other Standards BRIDG to other physical structures can be pre-built

  17. Step 6 : Study Analysis Statistical analysis, reports, and visualization will leverage standardized data

  18. Questions?

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