TransCelerate BioPharma Publishes Resources to Accelerate Industry Adoption of Newly-Released ICH E6(R3) Guidelines

New tools support sponsors in operationalizing important new guidelines to advance clinical trial conduct worldwide

PHILADELPHIA, March 3, 2025 /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 13 tools designed to assist pharma R&D sponsors and their ecosystem partners in adapting to the newly issued ICH E6(R3) Good Clinical Practice (GCP) guidelines. The new global guidelines, released in January by the International Council for Harmonization of Technical Requirements for Human Use (ICH), emphasize flexibility, efficiency, and data quality in the conduct of clinical trials.

In anticipation of these new guidelines, TransCelerate assembled a team of experts to evaluate the guidance and develop tools to support adoption of ICH E6 (R3). The array of tools announced today covers six focus areas: risk proportionality, monitoring, trial design, risk management, investigators, and data governance.

"The new guidelines represent an important step forward in protecting the safety, rights, and well-being of trial participants, enhancing the reliability of clinical trial data, and encouraging innovative approaches to trial design and use of technology. They will guide sites, sponsors and their service providers around the world to embrace quality by design and to act in a way that's fit for purpose and proportionate to the associated risks. These tools are designed to help stakeholders interpret and apply the guidelines and associated concepts," said David Nickerson, Head of Clinical Quality Management at EMD Serono, and executive sponsor of TransCelerate's ICH E6(R3) initiative. "Innovation in clinical research is at the heart of TransCelerate's work, and we're pleased to facilitate adoption of these new guidelines."

As a critical part of this initiative, TransCelerate partnered with the Association of Clinical Research Organizations (ACRO) to co-develop the tools related to risk management and data governance. This collaboration highlights the importance of leveraging shared expertise in addressing key challenges and optimizing clinical trial operations.

"ACRO is proud to partner with TransCelerate in developing essential tools to facilitate the industry's shift to a more flexible, risk-proportionate, and innovative approach to clinical trials, as outlined in the new ICH E6(R3) guidelines," said Sandy Kennedy, Chief Quality, Regulatory Affairs, & Sustainability Officer at Fortrea and Vice-Chair at ACRO. "By leveraging our collective expertise, we're confident these resources will help sponsors, CROs, and investigator sites optimize clinical trial operations—ultimately accelerating the delivery of new therapies to patients worldwide."

The full suite of tools is available on TransCelerate's website. TransCelerate is seeking input on two additional tools—Data Life Cycle Framework (co-developed with ACRO) and Trial Design Start-Up—as part of a public review. TransCelerate invites interested stakeholders (including sites, CROs, sponsors, academics and clinical trial vendors) to provide their perspectives and comments on these tools here.

TransCelerate will be hosting a webinar, Navigating ICH E6(R3): Tools & Resources for Understanding Changes and Supporting Adoption, from 9:00 to 10:30 a.m. EST on March 4, 2025, together with ACRO, to discuss the ICH E6(R3) guidelines and how sponsors can leverage newly developed tools to support implementation. For more information or to register, visit https://awarenessandimplementation.transceleratebiopharmainc.com/ich-e6.

For more information about TransCelerate's ICH E6(R3) work and to access the tools, click here.

About TransCelerate BioPharma Inc.
TransCelerate BioPharma (TransCelerate) is a non-profit organization that fosters collaboration across the global biopharmaceutical research and development community to drive innovation, simplify clinical trials and help bring new treatments to patients faster, safer and more efficiently. Headquartered in the Philadelphia area, TransCelerate has 20 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 transceleratebiopharmainc.com.

SOURCE TransCelerate BioPharma