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.
- 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 assets include:
- Digital Data Flow Overview
- Digital Data Flow Frequently Asked Questions