Clinical Data Standards Implementation

Situation:

Support the Dec 17, 2014 FDA binding guidance that all studies starting after Dec 17, 2016 must use the appropriate FDA-sponsored standards, formats, and terminologies specified in the Catalog for NDA, ANDA, and certain BLA submissions, in conformance with CDISC standards.

Business Goals:

  • Implement an MDR (Metadata Repository) for the storage and maintenance of clinical data standards
  • Implement Pinnacle 21 Enterprise to support Compliance Validation Checks, and Standards
  • Implement a Change Request and Workflow system to support Standards Governance
  • Develop and re-engineer operational processes to support the standards implenentation

 

Value Being Delivered:

CMK Select supported the Clinical & Statistical business teams through solution architecture, requirements development, vendor selection, process devleopment, application development, system testing, UAT script creation and UAT execution to bring Clinical Data Standards to a successful deployment.

 

BENEFITS REALIZED

  • Implemented according to tight timelines to meet the FDA binding guidance on the compliance to CDISC standards for all studies starting after Dec 17, 2016
  • Processes and tools to ensure SDTM Validation is compliant with CDISC SDTM standards
  • Implemented a single location for obtaining a set of standard operational and related SDTM metadata for CRFs (case report forms) used in key clinical trials

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