Collaborative Development Begins on Novel Digital Data Flow Solution for Study Start-Up

TransCelerate Biopharma Leading Effort to Facilitate Exchange of Structured Study Definitions Across Clinical Systems Using Technical, Data Standards

TransCelerate BioPharma Inc. has announced that it has commenced development on a reference implementation of a study definitions repository. The study definitions repository is a novel central component aimed at facilitating the exchange of structured study definitions across clinical systems using technical and data standards.

TransCelerate is leading the effort to design, build, and deploy the open-source, vendor agnostic solution with Accenture, the Clinical Data Interchange Standards Consortium (CDISC), and Microsoft. The solution provides a common foundation for industry-wide interoperability, capable of modernizing the way data flows across the clinical trials ecosystem.

Utilizing a standards-based study definitions repository may facilitate end-to-end digital data flow between upstream study design systems (e.g., study builders, protocol authoring tools) and downstream systems and documents used to execute a trial according to the protocol. This is expected to facilitate new levels of interoperability among clinical systems used across study design, start-up, and execution, paving the way for new innovations in the research and development (R&D) technology landscape and more seamless, open collaboration among research partners.

“This new solution has the potential to be more transformative for the R&D ecosystem than anything TransCelerate has embarked on before,” said Dalvir Gill, PhD, CEO at TransCelerate. “We’ve already created tools for content reuse throughout the clinical lifecycle, like the Common Protocol Template and the Clinical Template Suite. This new endeavor can create more dynamic flow of data across people, processes, and technology, helping the ecosystem shift away from document-based content and further toward our ambitions to automate clinical trials.”

“Biopharma has a tremendous opportunity to automate setting up and running clinical trials so they can be faster and more efficient,” said Stuart Henderson, Global Life Sciences Lead at Accenture. “With digital data flow, they will have an open-source solution capable of enabling end-to-end data flow across systems residing within the same company and across multiple organizations leveraging different systems. Collaboration between sponsors continues to grow and this will enable [contract research organizations], clinical technology vendors, and others to join TransCelerate on this journey to explore how we can enable the accelerating digital transformation of R&D.”

Microsoft will play a key role in solution architecture and provide technology used to power the study definitions repository reference implementation. To demonstrate initial viability, Azure solutions will be leveraged. The ultimate goal through this collaboration is to deliver a cloud-agnostic, open-source solution for the wider industry.

CDISC, a nonprofit that develops and advances standards, will develop the technical and data standards employed by the solution. As part of the standards-setting process, CDISC will oversee a public call for stakeholders across the ecosystem to participate in development. Organizations across the R&D ecosystem will be able to leverage the source code and developed standards to deploy their own study definitions repository implementations. A future model for verifying a specific deployment’s compatibility with standards, and thus interoperability with other systems, is planned.

Edited by Gary Cramer