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Digital Data Flow

DDF Overview

What is the Digital Data Flow initiative?

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The Digital Data Flow (DDF) initiative aims to modernize clinical trials by enabling a digital workflow that allows for automated creation of study content 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.

Watch a video describing the DDF Initiative.

What is the objective of the DDF initiative?

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The objective of DDF is to automate and expedite the Study Start-Up process by revolutionizing how data flows across clinical trial systems, beginning with upstream (e.g., study builder) and downstream (e.g., electronic data capturing/EDC, clinical trial management system/CTMS) clinical systems.

TransCelerate has collaborated to develop an open-source, vendor agnostic, study definition repository (SDR) reference implementation. The SDR's basis is a Unified Study Definitions Model (USDM), developed by CDISC, that standardizes the data model for protocol study definitions..

The SDR reference implementation enables the format of information from a digitized protocol and other sources to be standardized and stored centrally. This allows the information to be passed to systems through application programming interfaces (APIs) used for study execution and data collection and reused throughout the clinical development lifecycle.

In summary, DDF will combine data standards and a novel technology to enable the flow of data across all systems involved in the design and execution of a clinical trial.

Additional details regarding the USDM

To create a consistent, comprehensive, and structured representation of a study definition as described in text in clinical trial protocols, a Unified Study Definitions Model has been developed by CDISC.

The USDM contains both new and existing standards, and also provides common vocabulary, reusable designs, industry best practices, standards, and general implementation guidance for solution architects.

To learn more and get access to the USDM documentation, please go to the CDISC Digital Data Flow website.

Watch a video describing the USDM.

Additional details regarding the SDR Reference Implementation

The Study Definitions Repository is a novel central component aimed at facilitating the exchange of structured study definitions across clinical systems using both technical and data standards.

Transcelerate, along with Accenture, Microsoft, and other life sciences technology vendors have developed a working instance of the Study Definitions Repository based on the USDM called the Study Definitions Repository (SDR) Reference Implementation.

The SDR Reference Implementation has been designed and developed to be open-source and vendor agnostic. The goal of having an open-source, vendor agnostic solution is to create a platform for both innovation and collaborative interoperability across the industry.

Watch a video describing the SDR RI.

What are the benefits of the DDF initiative?

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Many companies still manually conduct many of the activities that support the process of moving data from protocol development through clinical trial execution and beyond.

Digital Data Flow (DDF) benefits include:

- minimized process hand-offs, data re-entry, and data format inconsistencies across study start-up and execution

- a foundation for data exchange and interoperability between clinical technology systems, leading to greater compatibility among systems, flexibility for sponsors, and improved clinical trial efficiencies

- a more seamless flow of data, leading to accelerated study start-up and further enabling trial automation for sponsors and research partners, and

- data format harmonization that can support greater interoperability and spark innovation within the research and development ecosystem and across the clinical trial solutions landscape.

Who does the DDF initiative help?

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The DDF initiative will help many organizations, including pharmaceutical companies, CROs, standards organizations, upstream and downstream clinical vendors, sites, regulatory agencies, technology companies, and the open-source pharmaceutical and IT communities.

With DDF, organizations across the R&D ecosystem will be able to leverage the open-source code of the SDR reference implementation and develop a framework to deploy their own SDR implementations.

Watch a video describing the benefits DDF initiative.

For more information on the DDF initiative on the TransCelerate BioPharma Inc. website, click here.