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Digital Data Flow

Rationale

Currently, there exists an average lag time of four months between protocol completion and study start. Furthermore, third-party conversion of data to SDTM lengthens cycle time and presents limits for traceability and re-use. Finally, working in a document-based environment results in significant manual duplication of effort.

This initiative aims to move the drug development process from a current state of manual, study start-up asset creation (i.e. Case Report Forms, Procedure Manuals, Statistical Analysis Plans, and Schedule of Activities) to a future state of fully-automated, dynamic, study start-up readiness via an open-sourced, vendor-agnostic technical solution that will reduce cycle times and improve data quality for sponsors, third-party providers, sites and regulators.

Benefits

Near-term:

  • Accelerate study start up
  • Allows for more efficient SDTM compliance
  • Increase data transparency
  • Accelerate asset readiness

Long-term:

  • Enable platform trial design and set up
  • Facilitate digital / remote trials
  • Use of machine learning / artificial intelligence to automate and reduce cycle time

Available Assets

Please check back for more information.

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