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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