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.



  • Accelerate study start up asset readiness
  • Minimize bottlenecks between processes and systems
  • Eliminate need for reconciling across study start-up assets, improving consistency and quality
  • Execute automatic propagation of changes and amendments required post study start-up across assets
  • Encourage and facilitate a vendor agnostic solution


  • Take advantage of innovative technologies to automate and enhance creation of study start-up assets
  • Expand connectivity beyond study start-up related systems
  • Enable platform trial design and set-up

Available Assets

Available assets include:

  • Solution Framework & Conceptual Design
  • Executive Summary
  • Appendix describing a technology-enabled business process for defining a clinical study design supported by a Study Builder platform

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Clinical Content & Reuse


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