TransCelerate BioPharma (TransCelerate), a nonprofit organization dedicated to improving the health of people around the world by accelerating and simplifying clinical research, has officially announced significant progress on its Digital Data Flow (DDF) initiative.
According to certain reports, this particular development arrives on the back of company’s recent DDF: Mission Possible! Practical Approaches for Protocol Digitalization events in the U.S. and Europe. During the stated event, sponsors, regulators, and solution providers came together to enjoy interactive sessions on digital protocols, standards, and solutions.
More on that would reveal the same how TransCelerate’s progress also builds on the introduction of version 4 from the Unified Study Definitions Model (USDM) which, on its part, is developed by Clinical Data Interchange Standards Consortium (CDISC). For better understanding, USDM v4 arrives on the scene bearing an ability to provide one standardized, machine-readable format for capturing clinical trial protocol information, eventually creating a setup poised to facilitate automation, interoperability, and data reuse across the trial lifecycle.
“As an industry, we’re seeing real momentum build around digital protocols,” said Michelle Rohrer, Senior VP, Global Head, Product Development Regulatory, Roche and TransCelerate board member. “Sponsors are embracing DDF; implementation sets them up not only to comply with evolving regulatory specifications such as ICH M11 but also to improve efficiency and quality in regulatory documentation because data exchange is automated. We’re also seeing more solution providers demonstrate innovation and efficiency through utilization of the standard and broad collaboration across the ecosystem. I have witnessed this progress over many years; I believe we are now at a turning point.”
To understand the significance of such a development, we must take into account how, even with all the industry advances, including adoption of a common protocol template (first released by TransCelerate in 2015), today’s clinical trial protocols continue to fall short of being fully digitized.
You see, an estimated 90% are created and managed as unstructured documents, something which significantly slows down study start-up, requires duplication of effort, and limits both data reuse and patient access to key trial information.
Against that, TransCelerate’s approach focuses on converting protocols into structured, digital data, while simultaneously enabling more connected, efficient trials.
Markedly enough, the push in question from TransCelerate also builds mark an extension for several key factors driving industry adoption of digital protocols.
These factors begin from regulatory readiness, as global regulators are steadfastly pivoting towards structured, digital protocols. Owing to that, early adopters of USDM are better positioned to align with guidance, such as ICH M11, and prepare for digital-first submissions.
We must also expand upon the prospect of industry implementation. Sponsors and solution providers across the ecosystem are increasingly adopting DDF, spanning the majority of TransCelerate’s member companies, who collectively invest $125 billion annually in R&D. Not just that, even vendors, sponsors, and standards bodies are building on a common model, thus laying the groundwork for interoperability, analytics, and AI enablement.
“Digital protocols aren’t just more efficient — they’re transformational in their power to reshape how trials are executed,” said Robert DiCicco, Vice President of Portfolio Management at TransCelerate BioPharma. “They create the opportunity for higher-quality data and a more connected ecosystem where insights can be shared and reused across the research community. Developing something that reflects inputs from a diverse group of stakeholders and is publicly available – all to advance the delivery of new medicines to patients – is the essence of TransCelerate.”
