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 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

Initiative Solutions

Available assets include:

Digital Data Flow Overview
Digital Data Flow Frequently Asked Questions

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