The Power of Forward is commitment in action.
In 2025, we saw how powerful that commitment can be. Together with our members and partners, we made progress that was both immediate and enduring.
We advanced tools that make trials simpler for patients and sites, and we are forging the connections to bridge the gap between research and care.
We expanded collaboration with health authorities and industry stakeholders, showing what’s possible when the ecosystem moves forward together.
And we enabled industry to break new ground—from digitizing protocols that streamline how studies are designed to data sharing that is supporting complex, pioneering use cases.
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.
THE POWER OF FORWARD
Our Vision and How We Delivered in 2025
2025 showed what it means to move forward with purpose.
Pressures grew, change accelerated—yet progress didn’t falter.
Our vision is one where data flows, innovation takes flight and patients see the benefit sooner.
The Power of Forward was clear in the milestones we delivered in 2025:
Sponsors continued to adopt DDF, including the majority of our member companies, while growing interest from solution providers showed that digital protocol innovation is moving from early pilot to everyday practice.
A manuscript in a prominent journal, Drug Safety, and dialogue with multiple health authorities marked crucial first steps toward modernizing safety data management.
These milestones prove the Power of Forward: concrete progress today, lasting impact tomorrow.
Fifteen practical tools released in 2025 gave the industry ways to adapt to new guidance on good clinical practice—earning wide media coverage along the way.
This year’s FDA tabletop exercise and new resource guide reinforced pragmatic approaches as promising strategies to make trials more inclusive and accessible.
Usage more than doubled, demonstrating the growing impact of data reuse to reduce burden and improve trial design.
These milestones prove the Power of Forward: concrete progress today, lasting impact tomorrow.
As a non-profit consortium of leading biopharma companies, TransCelerate was created to tackle challenges no single company could solve alone.
Over the past decade, that model has scaled globally:
With this reach comes readiness: to help unlock data interoperability, enable inclusive trial design and take on challenges that demand collaborative innovation.
Keeping pace with new regulatory guidance and expanding trial demands posed challenges across the ecosystem. Practical ICH E6(R3) tools and insights from Optimizing Data Collection’s review of more than 100 protocols pointed the way to simpler, smarter design.
Manual data transfer has long impeded the flow of information. In 2025, DDF further demonstrated how digitized protocol data can reduce redundancy and create the foundation for interoperability at scale.
The complexity of safety analyses continued to grow. Modernizing ICSR Management brought multiple health authorities to the table, while Enabling Translational Safety made strides in developing a terminology translation tool with input from the FDA to enable linking of preclinical and clinical data for toxicology safety analysis.
Barriers to participation remain. In 2025, progress centered on helping sponsors incorporate pragmatic elements into traditional trials—simplifying design, broadening access and improving representativeness. Modernizing Clinical Trial Conduct resources further reduced the burden for sites and participants.
One organization innovates. An ecosystem transforms.
With Tufts Center for the Study of Drug Development (CSDD), we published a benchmarking study on protocol complexity, strengthening the evidence base for Optimizing Data Collection.
Dialogue expanded across four continents, with our support of FDA’s PRISM M11 pilot an example of productive collaboration, and regulator presence at our DDF: Mission Possible event.
Engagement spanned both events and media, with nearly 2,000 registrants for our flagship ICH E6(R3) webinar, and coverage of TransCelerate’s work and perspectives in 50+ publications worldwide.
In 2025, TransCelerate presented at major conferences across North America, Europe, Asia and South America, from Baltimore to Brussels to Tokyo to Buenos Aires.
TransCelerate’s member companies collectively invest more than
in R&D every year.
Our members share a commitment to accelerating clinical research, and to turning that investment into tangible progress for patients.
That commitment comes to life in the words of our leaders and board members:
"In 2025, TransCelerate once again demonstrated the power of collaboration to accelerate simplification in clinical research. The body of work advanced last year delivered swift support on near-term needs while still building momentum on longer-term transformative opportunities. No single company could achieve alone what we are accomplishing together, and I am proud to guide the effort."
“Innovation in pharmaceutical development must address today’s needs and tomorrow’s patient care. By forging meaningful collaborations, we can enable patient-centric and faster clinical development for better long-term outcomes. My vision for TransCelerate is to continue building a focused framework that drives our ambition forward within an ever-evolving environment.”
Dr. Eliav Barr
Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, MSD; Chair, TransCelerate Board of Directors
Lykke Hinsch Gylvin
Chief Medical Officer, Head of Global Medicine, Boehringer Ingelheim; TransCelerate Board Director
"In 2025, TransCelerate once again demonstrated the power of collaboration to accelerate simplification in clinical research. The body of work advanced last year delivered swift support on near-term needs while still building momentum on longer-term transformative opportunities. No single company could achieve alone what we are accomplishing together, and I am proud to guide the effort."
Dr. Eliav Barr
Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, MSD; Chair, TransCelerate Board of Directors
“Innovation in pharmaceutical development must address today’s needs and tomorrow’s patient care. By forging meaningful collaborations, we can enable patient-centric and faster clinical development for better long-term outcomes. My vision for TransCelerate is to continue building a focused framework that drives our ambition forward within an ever-evolving environment.”
Lykke Hinsch Gylvin
Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, MSD; Chair, TransCelerate Board of Directors
TransCelerate’s solutions create a ripple effect across the global research community, from large sponsors to NGOs that adapt our tools to enable research in underserved regions.
“TransCelerate’s site education toolkits have revolutionized research in the Middle East and across the African continent. We are thrilled to be using these same materials to help improve healthcare through our partnership with the Pan African Parliament and engagement with payers, physicians and patients.”
Mimi Choon-Quiñones
Founder & Board Chair, Partners for Patients NGO; Pan African Parliament Honorary Ambassador for Public Health and Global Health
As we move forward in 2026, our focus is on what will push the ecosystem further forward.
DDF is moving from pilots to scale, bringing greater efficiency, quality and simplification to how protocol data is created and shared. At the same time, TransCelerate is exploring ways to connect digital protocols with electronic health records for specific clinical research use cases that benefit patients, providers and sponsors alike.
Conversations around AI are accelerating, shaping how it can responsibly move pharma ahead. More collaborative forums are emerging to reimagine how data is sourced, structured and shared.
The vision remains bold: seamless convergence of research and care, so that trial participation becomes a natural part of healthcare processes.
And the mindset is clear: the courage to test, adapt and keep catalyzing change—together.