Nonprofit biopharma consortium details progress in digital data flow, pragmatic trial design, safety modernization, and regulatory engagement in “The Power of Forward.”
TransCelerate BioPharma has released its 2025 annual report, titled The Power of Forward, outlining a year defined by continued digital adoption, regulatory collaboration, and expansion of pragmatic approaches to clinical development.1
Framed against a backdrop of economic pressure, evolving regulations, and increasing scientific complexity, the report positions 2025 as a year in which the consortium’s collaborative model helped sustain momentum across the research ecosystem.
In a statement on the organization’s website, CEO Janice Chang said: “This year’s story is one of persistence and progress: delivering today while paving the way for what’s next, always with patients at the center.”
A central theme was the continued uptake of Digital Data Flow (DDF), an initiative to standardize and digitize protocol data. According to the report, the majority of member companies have now adopted DDF, with growing engagement from technology providers signaling a shift from pilot efforts to broader operational use. TransCelerate describes DDF as foundational to reducing manual data transfer and enabling interoperability at scale.
Regulatory alignment also featured prominently. In response to the finalized ICH E6(R3) guidance on good clinical practice, TransCelerate released 15 practical tools designed to support implementation. The materials were accompanied by global engagement, including a webinar that drew nearly 2,000 registrants. The consortium reported more than 200 interactions with health authorities in 2025, spanning four continents.
Safety modernization efforts advanced through work on individual case safety report (ICSR) management. Publication of a manuscript in Drug Safety and dialogue with multiple regulators marked early steps toward rethinking how safety data are managed. Separately, work on translational safety included development of a terminology translation tool intended to help link preclinical and clinical toxicology data, with input from the FDA.
Efforts to simplify trial design and improve access also continued. An FDA tabletop exercise and a new resource guide reinforced pragmatic trial approaches aimed at broadening participation and reducing burden. Meanwhile, usage of TransCelerate’s clinical data sharing platform more than doubled in 2025, reflecting increased interest in data reuse to inform study design and reduce redundancy.
The organization also expanded external partnerships. Collaboration with the Tufts Center for the Study of Drug Development (CSDD) produced a benchmarking study on protocol complexity, supporting its Optimizing Data Collection initiative. Engagement with regulators included support of the FDA’s PRISM M11 pilot, as well as participation in major scientific conferences worldwide.
TransCelerate’s member companies collectively invest more than $130 billion annually in research and development. Leadership emphasized that the consortium’s model allows competitors to collaborate on shared operational challenges that no single sponsor could address independently.
Looking ahead to 2026, the
Last year, Applied Clinical Trials highlighted research conducted by the Tufts CSDD and TransCelerate on optimizing clinical trial data.2
According to the analysis—which included 15 TransCelerate member companies and reviewed 105 multi-therapeutic protocols completed after 2018—data volume continues to climb, with a significant share tied to non-core or non-essential procedures.
Key findings included:
On an
1. The Power of Forward: Annual Report 2025. TransCelerate BioPharma.
2. Kenneth Getz, Emily Botto, Ana Calduch Arques et al. Insights informing strategies for optimizing the collection of clinical trial data, 14 September 2025, PREPRINT (Version 1) available at Research Square [
