PHILADELPHIA–(BUSINESS WIRE)–TransCelerate BioPharma Inc. (TransCelerate) announced today 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. TransCelerate is building a reference implementation of a study definitions repository to encourage future open-source development and deployment of this concept across the clinical trials ecosystem. 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 R&D technology landscape and more seamless, open collaboration among research partners.
Potential benefits of such a solution include:
- Minimized process hand-offs, data re-entry, and data inconsistencies across study start-up and execution
- A foundation for interoperability between clinical technology systems, leading to greater compatibility among systems and flexibility to sponsors
- More seamless flow of data, leading to accelerated study start-up and further enabling trials automation for sponsors and 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, Ph.D., 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.”
“The project is a significant step toward accelerating study start-up,” said Badhri Srinivasan, Head, Global Development Operations, Novartis, and a Board of Directors member of TransCelerate BioPharma. “We have a responsibility to patients to ‘work smarter, not harder’ in the way we manage and apply data in research and development. Collaborating across stakeholders will help us advance much further and more effectively than we otherwise could alone – this is truly an example of transformation that requires full ecosystem involvement.”
As part of this collaboration, each organization fulfills a key role. TransCelerate, through its Digital Data Flow Initiative, will continue to oversee the project on the effort and will contribute across all components of solution development while seeking to engage other stakeholders in the ecosystem and build a strategy for long-term governance.
Accenture will support TransCelerate in leading the delivery and development of the solution and work with Member Companies to understand the requirements to integrate this solution into their broader technology landscapes.
“Biopharma has a tremendous opportunity to automate setting up and running clinical trials so they can be faster and more efficient. 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,” said Stuart Henderson, Global Life Sciences Lead at Accenture. “Collaboration between sponsors continues to grow and this will enable CROs, 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.
“Microsoft is pleased to help accelerate and empower innovation and reduce time to market of new therapies,” said Patty Obermaier, Vice President, U.S. Health and Life Sciences at Microsoft. “We are looking forward to doing our part to leverage our technologies and investments in innovation along with the expertise of our fellow collaborators and customers to transform R&D.”
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.
“By unifying existing standards and developing new standards with input from all potential end users, we will enable the accessibility, interoperability, and reusability of protocol-related study definitions data. Working on the implementation with TransCelerate and these other organizations, we expect to amplify the value of this data and make a positive impact on clinical research,” said Dave Evans, President and CEO at CDISC.
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.
TransCelerate and its partners invite participation from all interested stakeholders and will be setting up mechanisms to facilitate engagement. Those interested in getting involved by providing feedback and input on the study definitions repository reference implementation development can submit their contact details and their level of interest through the Digital Data Flow feedback form.
About TransCelerate BioPharma, Inc.
TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by accelerating and simplifying the research and development (R&D) of innovative new therapies. The organization’s mission is to collaborate across the global biopharmaceutical R&D community to identify, prioritize, design, and facilitate implementation of solutions intended to drive the efficient, effective, and high-quality delivery of new medicines. The vast majority of TransCelerate solutions are publicly available. Headquartered in Philadelphia, TransCelerate has 20 member companies and 30+ initiatives focused on improving the patient and site experience, enhancing sponsor efficiencies and drug safety and, as appropriate, harmonizing process and sharing information.
Membership in TransCelerate is open to pharmaceutical and biotechnology companies with R&D operations. For more information, please visit http://www.transceleratebiopharmainc.com, https://twitter.com/TransCelerate, or https://www.linkedin.com/company/transcelerate-biopharma-inc-/.