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 Study Data Tabulation Model (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. 

The Digital Data Flow (DDF) initiative aims to modernize clinical trials by enabling a digital workflow to allow for the automated creation of study assets and configuration of study systems to support clinical trial execution. This initiative will establish a foundation for a future state of automated and dynamic readiness that can transform the drug development process. 

Benefits

  • Facilitate consistency of data 
  • Minimize bottlenecks between processes and systems 
  • Minimize manual work, data re-entry, and data inconsistencies  
  • Improve clinical trial efficiencies by achieving seamless information flow across multiple systems 
  • Spark innovation that will generate new technologies and features, most notably interoperability and automation 

Available Solutions

Available assets include:

  • Digital Data Flow Overview
  • Digital Data Flow Frequently Asked Questions

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