TransCelerate BioPharma Inc. announced that it has begun development of a reference implementation of a study definition repository. The study definition repository is a new type of central component that is intended to facilitate the exchange of structured study definitions across clinical systems using technical and data standards.
TransCelerate, together with Accenture, the Clinical Data Interchange Standards Consortium (CDISC) and Microsoft, is leading efforts to design, develop and deploy the vendor-independent open source solution. The solution provides a common foundation for industry-wide interoperability and can modernize the flow of data across the clinical trial ecosystem.
Using a standards-based repository for study definitions can facilitate end-to-end digital data flow between upstream study design systems (e.g. study creators, protocol authoring tools) and downstream systems and documents used to conduct a study according to the protocol. This is intended to enable a new level of interoperability between clinical systems used in study design, launch, and execution, and pave the way for new innovations in the research and development (R&D) technology landscape and more seamless, open collaboration between research partners.
“This new solution has the potential to be more transformative to the R&D ecosystem than anything TransCelerate has done to date,” said Dalvir Gill, PhD, CEO of TransCelerate. “We have already developed tools for content reuse throughout the clinical life cycle, such as the Common Protocol Template and the Clinical Template Suite. This new venture can create a more dynamic flow of data between people, processes and technology, and help the ecosystem shift away from document-based content and move towards our ambitions to automate clinical trials. “
“Biopharma offers a tremendous opportunity to automate the process of setting up and running clinical trials to make them faster and more efficient,” said Stuart Henderson, global life sciences lead at Accenture. “With digital data flow, they have an open source solution that enables end-to-end data flow across systems within the same company and across multiple organizations that use different systems. The collaboration between sponsors continues to grow and this will make it possible [contract research organizations], Clinical technology providers and others joining TransCelerate on this journey to find out how we can enable accelerated digital transformation of R&D. “
Microsoft will play a key role in the solution architecture and will provide technology that will be used to support the reference implementation of the study definition repository. Azure solutions are used to demonstrate the initial feasibility. The ultimate goal of this collaboration is to provide a cloud-agnostic open source solution for the entire industry.
CDISC, a non-profit organization that develops and promotes standards, will develop the technical and data standards that will be used by the solution. As part of the standard setting process, CDISC will monitor a public call to stakeholders across the ecosystem to get involved. Organizations across the R&D ecosystem will be able to leverage the source code and developed standards to provide their own repository implementations for study definitions. A future model for checking the compatibility of a particular deployment with standards and thus interoperability with other systems is planned.
Edited by Gary Cramer