TransCelerate BioPharma Inc.

DIA Japan 2025 kicks off this week! TransCelerate will join global stakeholders to share insights on the future of clinical research and the power of collaboration. Don’t miss our two sessions: “Clinical Trials 2035: Innovations That Will Transform the Future of Research,” featuring TransCelerate CEO Janice Chang, and “Accelerating ICH M11 Implementation: International Collaboration Across Stakeholders for Innovation with the Digital Protocol.”    Learn more: https://lnkd.in/eu9FHmuB 

"Digital protocols aren't just more efficient — they're transformational in their power to reshape how trials are executed," said Rob DiCicco, Vice President of Portfolio Management at TransCelerate. At our recent DDF: Mission Possible event in the U.S. and Europe, that transformation was evident as global stakeholders discussed the regulatory readiness, industry adoption, and collaboration reshaping clinical trials into a more digital and connected future. Read: https://lnkd.in/eWj6BnJb  

Did you catch the fall edition of Pulse on Progress?  It features new resources from our Modernizing Clinical Trial Conduct (MCTC) initiative, highlights from our visit with Astellas, and a look at what’s coming next. Read: https://lnkd.in/eW88jrRg  

The Common Protocol Template (CPT) is changing! The revised CPT will align with the ICH M11 Protocol Template, which is expected to launch later this year. To help sponsors with implementation planning, a preview draft of the CPT Basic Word edition and supporting materials are now available. We expect to release the final version in early 2026. Explore: https://lnkd.in/dYEjkMwJ  

Catch us this week at SCOPE Europe! TransCelerate will take part in six sessions across the conference, including two on Wednesday, October 15, featuring Rob DiCicco, Vice President of Portfolio Management, who will discuss unlocking the potential of electronic health data to accelerate clinical research and using digital automation to streamline study start-up and reduce effort. Learn more: https://lnkd.in/e4nuFjHB  

The Medicine Maker has published part two of its series on ICH-E6(R3). This installment features insights from David Nickerson (EMD Serono) and Arlene Lee (ACRO), members of the TransCelerate x ACRO ICH-E6(R3) team, who discuss the free toolkit designed with the goal to help stakeholders implement the new Good Clinical Practice guideline and modernize clinical research. Read: https://lnkd.in/gzjkBy8h  

We’re heading to SCOPE EU next week in Spain—and hope to see you there!  TransCelerate will take part in sessions covering topics such as trial design and protocol development, embedding trials into clinical practice, amplifying the patient voice in trial design, and more. Learn more: https://lnkd.in/e4nuFjHB  

Cooler days, fresh updates.  The fall edition of TransCelerate’s Pulse on Progress is live! Discover new resources from our Modernizing Clinical Trial Conduct (MCTC) initiative, highlights from a member company visit with Astellas, and upcoming events you won’t want to miss. Read: https://lnkd.in/eW88jrRg  

The Medicine Maker recently published the first in a two-part Q&A series featuring David Nickerson (EMD Serono) and Arlene Lee (ACRO), both members of the TransCelerate x ACRO ICH-E6(R3) risk management team. They share insights on the updated guideline and why this change was so important and needed for the industry. Read: https://lnkd.in/eabbY9qg  

Featured in Informa TechTarget, Allison Cuff Shimooka, TransCelerate’s Chief Operating Officer, shares thoughts on structural challenges that limit equitable access to clinical research and ways technology can be leveraged – with intention – to help.  Read: https://lnkd.in/eRsBh58q