TransCelerate - Digital Data Flow Asset

Digital Data Flow

This initiative aims to advance the drug development process by enabling clinical trial protocol digitalization, helping to move the industry from a document-centric to a data-centric approach. With this change, Digital Data Flow has the potential to reduce cycle times, improve data reliability and quality for sponsors, third party providers, sites and regulators.

Rationale

Clinical trial protocols serve as the anchor for specifying clinical trial requirements and parameters. Currently, protocols do not exist in a common, machine-readable format that can be easily exchanged among disparate systems. An average lag time of 4 months exists between protocol approval and study start up. Furthermore, converting data to Study Data Tabulation Model (SDTM) by third parties lengthens cycle time and limits traceability and re-use. Finally, working in a document-based environment results in significant manual duplication of effort.

By starting with the Unified Study Definitions Model (USDM), an industry standard data format used during study design, the Digital Data Flow initiative offers a mechanism to digitize clinical study components to enable automation, interoperability, and reuse across the study lifecycle.

The Digital Data Flow initiative will help modernize clinical trials by enabling a digital workflow. Such a workflow will enable automated study asset creation and study system configuration 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.

How We’re Enabling Clinical Trial Protocol Digitalization

TransCelerate has collaborated with CDISC and other stakeholders to develop a standard data model for specifying protocol information, as well as a demonstrated way to connect systems that produce, exchange, or consume this information.

Our approach centers around 3 key principles:

Digital Data Flow Initiative Roadmap

Benefits

Eliminate non value-added activities through automation: “Work Smarter Not Harder”
Enable flexible company and/or industry-wide interoperability by applying clinical protocol standards
Create foundation for study design analytics insights

Related Initiatives

Clinical Content & Reuse

What is Clinical Content & Reuse (CC&R) Click on the Harmonized Model Content, Reuse Capabilities and Clinical Template Suite sections to learn more about CC&R. The Clinical Content & Reuse (CC&R) Initiative enhanced clinical trial processes by providing harmonized structure and proposed model content within clinical trial documents that can be reused throughout the project…

Clinical Data Standards

Clinical data are reported by individual trials in various ways which may cause a labor intensive process to gain data insights. The Clinical Data Standards Initiative, in collaboration with CDISC (Clinical Data Interchange Standards Consortium), C-Path (Critical Path Institute), NCI- EVS (National Cancer Institute – Enterprise Vocabulary Service) and FDA as part of the CFAST (Coalition For Accelerating Standards and Therapies), aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and metadata, while improving patient safety and clinical trial outcomes.

eSource

The eSource Initiative aimed to assist sponsors in overcoming challenges in moving towards more efficient data gathering practices to benefit patients, sites and sponsors.