TransCelerate - Digital Data Flow Asset

Digital Data Flow

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.

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 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

Long-term:

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 Solutions

Initiative Solutions

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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