TransCelerate BioPharma Releases 2025 Annual Report Highlighting The Power of Forward in Clinical R&D

Report showcases how cross-industry collaboration translates complex challenges into practical solutions while laying the foundations for the future of clinical research

PHILADELPHIA, Feb. 19, 2026 /PRNewswire/ -- TransCelerate BioPharma (TransCelerate), a global nonprofit organization dedicated to improving the health of patients by accelerating and simplifying the clinical R&D process, today announced the release of its 2025 Annual Report, The Power of Forward. The report highlights how TransCelerate and its member companies translated complex industry challenges into practical solutions in 2025, while laying the groundwork for long-term transformation across the clinical R&D ecosystem.

Throughout 2025, pharmaceutical R&D operated under mounting pressure driven by increasing therapeutic and scientific complexity, shifts in regulatory expectations, and the urgent need for streamlined trial operations. During this period, TransCelerate advanced collaborative initiatives that addressed immediate challenges while building momentum toward a more connected, patient-focused future for clinical research.

"What stood out to me most about 2025 was how quickly the right kind of collaborative work can show results, while also laying foundations that compound over time," said Janice Chang, CEO of TransCelerate. "We delivered progress that was both immediate and enduring, turning complex ideas into practical tools. The Power of Forward reflects our belief that real change comes from steady, collective work – strengthening dialogue with regulators, reducing burden for patients and sites, and advancing smarter, simpler clinical research that brings new therapies to patients faster."

Advancing Progress Across Clinical R&D in 2025

TransCelerate's 2025 Annual Report highlights measurable progress across its portfolio, including:

• Digital Data Flow (DDF): By September 2025, a majority of TransCelerate's member companies had shared that they were making progress in their DDF implementation efforts, signaling a major inflection point toward more digitized, interoperable protocols that can streamline trial execution and data exchange.
  
  
• ICH E6(R3) Adoption: TransCelerate released 15 practical tools to support implementation of the long-anticipated updates to Good Clinical Practice guidelines, with strong global interest, including nearly 2,000 registrants for its flagship webinar.
  
  
• Clinical Data Sharing: Use of the DataCelerate platform more than doubled from the previous year, alongside continued growth in peer-reviewed publications highlighting scientific value from shared datasets.
  
  
• Patient Safety Modernization: Seven health authorities across three continents engaged in open dialogue on modernizing individual case safety reporting, reinforcing shared interest in more efficient, actionable safety monitoring.
  
  
• Embedded Pragmatic Trials: In collaboration with the FDA's Center for Drug Evaluation and Research (CDER), TransCelerate published a public summary of a joint tabletop exercise exploring how pragmatic elements can be applied in practice, along with a new resource guide for sponsors.

Scale, Collaboration, and Global Reach

The report underscores the scale that enables TransCelerate's impact, driven by collaboration among its global member companies and reflected in more than 500,000 downloads of publicly available tools across over 100 countries. To date, TransCelerate has engaged with health authorities worldwide through more than 200 regulatory interactions. The organization has also supported more than 50 collaborations spanning four continents and shared insights at major international forums. Collectively, TransCelerate's member companies invest more than $130 billion annually in R&D, underscoring the scale of commitment to resolve common problems that slow the delivery of new medicines to patients.

Looking Ahead: What's Next

Looking ahead to 2026 and beyond, TransCelerate's priorities focus on enabling digital protocols for regulatory use, leveraging electronic health records to help make trial participation a more seamless extension of care, and expanding collaborative forums that encourage shared learning, experimentation, and continuous improvement across the clinical R&D ecosystem.

About TransCelerate BioPharma Inc.
TransCelerate BioPharma (TransCelerate) is a nonprofit organization that fosters collaboration across the global biopharmaceutical research and development community to simplify clinical trials and help bring new treatments to patients faster, safer, and more efficiently.
Headquartered in the Philadelphia area, TransCelerate has 18 member companies and a robust portfolio of initiatives focused on transforming connectivity, enabling information sharing and reuse, and driving innovative trial designs. For more information, please visit https://www.transceleratebiopharmainc.com/who-we-are/.

SOURCE TransCelerate BioPharma