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How TransCelerate, Microsoft, Accenture, and CDISC are Working to Revolutionize Digital Data Flow

TransCelerate is thrilled to announce the launch of the Digital Data Flow Initiative’s Study Definition Repository Reference Implementation (SDR RI) Minimal Viable Product (MVP). The SDR RI is a model implementation of a repository that uses a Unified Study Definitions Model to facilitate data exchange.

The source code and configurations are available by means of an open-source license, enabling pre-production deployments by solution providers, life science companies, or academic research organizations. These materials can be found on TransCelerate’s GitHub page.

This exciting launch of the MVP is the result of years of planning and building on previously released TransCelerate solutions. It turns the “art of the possible” into reality by leveraging the power of collaboration.

The SDR RI aims to help organize, automate, and expedite the study start-up process by facilitating critical protocol-level information flow across three primary components:

  1. Upstream systems: Study builders or digital protocol authoring tools that produce digitized study definitions
  2. Downstream systems: Systems used to execute a clinical trial according to the protocol. These systems consume the digitized protocol as part of their configuration to start and execute processes of the clinical trial
  3. Study definition repository: A novel central component that will utilize industry technology standards and data standards to manage the information flow between upstream and downstream systems
TransCelerate's Study Definition Repository MVP release enables flow of study definitions data from study builders to Study Definitions Repositories to EDC/CDMS

Turning the “art of the possible” into reality

The development of this solution started four years ago and was inspired by another TransCelerate initiative. One of TransCelerate’s foundational solutions is the Common Protocol Template (CPT), which is now part of a suite of templates delivered by our Clinical Content & Reuse Initiative. CPT simplifies clinical trial processes by providing a common structure and model content for reuse across clinical trial documents and leveraging the power of existing data standards. Today, CC&R offers the CPT, Common Statistical Analysis Plan, and a Common Clinical Study Report. These are also offered as eTemplates to enable automation in downstream documents, processes, and registries. Since launching in 2015, the CPT is consistently one of the top downloaded and implemented solutions that we’ve released. Many sponsor companies now use it, as well as CROs and academic researchers—further highlighting its value.

It quickly became apparent to TransCelerate that creating a solution for automating data flow across the clinical study lifecycle was an opportunity that would benefit stakeholders across the ecosystem. Clinical development is the most expensive and time-consuming phase of delivering a new medicine to patients. Protocol information is curated many times manually as part of planning and execution, lengthening both start-up and overall cycle time, and delaying the availability of new medicines to patients.

The Study Definition Reference Implementation MVP is a key first step in breaking the document paradigm. Digitizing critical protocol information lays a foundation for automating and accelerating study start-up. It also will enable the aggregation of protocol data across studies to support smart design or analytics-driven trial design through machine learning and AI applications and foster greater innovation.

Digital Data Flow across the clinical trial study lifecycle.
Digital Data Flow across the study lifecycle. “Study definitions data” describe the design and definition of a study and include information such as objectives, endpoints, schedule of activities, I/E criteria, or other info found in a protocol document.

Three fundamental principles guide the current and future development work for DDF.

  1. It is a solution that is publicly available
  2. The solution needs to be vendor and cloud-agnostic
  3. An open-source approach will enable innovation more quickly

We think these principles will make it possible for stakeholders (sponsors, CROs, Health Authorities, sites, and technology providers) across the ecosystem to take advantage of the solution faster. It is also intended to foster collaboration to accelerate learnings.

Commencing collaborative development

TransCelerate is founded on the vision to improve the health of people around the world by accelerating and simplifying the R&D of innovative new therapies through co-created tools and resources.

While TransCelerate has a deep bench of subject matter experts on how to tackle digital data flow, for the Study Definitions Repository Reference Implementation to have the best chance of success, other organizations would need to be involved in the actual creation of the proposed solution.

In 2021, TransCelerate announced that it officially commenced development on the solution with Microsoft, Accenture, and CDISC. Each organization plays a critical role. TransCelerate’s Digital Data Flow Initiative will continue to oversee the project, contribute across all components of solution development, and seek to engage other stakeholders in the ecosystem and build a strategy for long-term governance.

Accenture leads the delivery and development of the solution and is developing tools to help companies integrate this solution into their broader technology landscapes.

Microsoft plays a key role in solution architecture and provides the technology used to power the study definitions repository reference implementation.

CDISC is currently developing the technical and data standards employed by the solution as part of a Unified Study Definitions Model. As part of the standards-setting process, CDISC oversees a public call for stakeholders across the ecosystem to participate in development.

TransCelerate, Microsoft, Accenture, and CDISC are making these deliverables available in the hopes that they will both move the needle and spark further innovation. 

How to participate

The release of the Study Definitions Repository Reference Implementation MVP is just the start of this journey. TransCelerate is seeking interested organizations to provide input to the next iteration of the solution, currently anticipated to release in early 2023.

A primer on the project can be found at “Digital Data Flow: Modernizing Clinical Trials, Updates on Progress and Cross-Industry Collaboration” with Part 2 found here. These webinars cover:

  • TransCelerate’s progress to date with the launch of the DDF MVP solution, including an overview of what has been developed and launched, how to access the code and content for the Study Definitions Repository Reference Implementation, and guidance on how to start adopting DDF within your own companies 
  • Find out how to collaborate and participate in modernizing clinical data flow with insights from our panel on the vision of DDF and value to our ecosystem of stakeholders across the clinical study value chain 
  • Explore the future possibilities of DDF using a tangible proof of concept including how to apply the DDF solution to future roadmaps

A virtual connect-a-thon is also planned for the fall, where participants can build working proof of concepts or prototypes that demonstrate the ability to connect and integrate digitized study definitions. Additional details about this event will be published on the TransCelerate DDF web page and TransCelerate DDF GitHub page in the coming weeks.

Interested to learn more? Fill out this feedback form to indicate your level of interest and how you would like to be involved.

Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. Rob joined TransCelerate from IBM Watson Health where he was the Deputy Chief Health Officer. At IBM he worked closely with software designers and developers to inform product roadmaps. Rob also conducted research to assess the performance of solutions applied in the e-clinical environment.

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