Austin, TX – 29 January 2025 – The Clinical Data Interchange Standards Consortium (CDISC) is proud to announce the appointment of Paul Fenton-Carter as Chair of the Trial Master File (TMF) Reference Model Steering Committee. Paul succeeds Karen Roy, who has served in this role for the past 11 years, making invaluable contributions to the advancement of clinical trial standards and processes.
Paul Fenton-Carter brings over 25 years of expertise in implementing technology-based solutions for regulated clinical trials. As the founder and CEO of Montrium, a global clinical operations-focused technology company, Paul has dedicated his career to improving the organization and analysis of clinical trial information. He holds an MBA in Technology Management from Université de Québec à Montreal and has led numerous initiatives to develop clinical research standards and platforms.
In addition to being a long-standing member of the TMF Reference Model Steering Committee, Paul has played a key role as Chair of the CDISC eTMF Standards Working Group. His deep understanding of the pivotal role of well-structured and standardized TMFs has helped shape industry best practices and global collaboration efforts.
Reflecting on his appointment, Paul said, "I’m honored to step into the role as Chair of the Trial Master File Steering Committee. Throughout my career in clinical research, I’ve come to understand how pivotal a well-structured and standardized TMF is - not just for the success of trials, but for the patients who depend on the breakthroughs they deliver. I look forward to working alongside this exceptional team to drive meaningful progress and advance global collaboration in clinical research."
Alongside Paul, Jamie Toth has taken on the role of Chair Elect. Jamie has been a long-standing member of the TMF Reference Model Steering Committee, and she has led multiple initiatives such as the TMF Plan Template, Relevant Communications for clinical trials guidance, and the Investigator Site File Reference Model.
Karen Roy, whose tenure as Chair has been instrumental in driving innovation, developing and strengthening the TMF Reference Model, shared her thoughts on her time in the role, "It has been a privilege to lead the TMF Reference Model Steering Committee over the past 11 years. Together, we’ve made significant strides in advancing the role of the TMF in improving clinical trial processes. Paul is the perfect person for this role as we move to Version 4 and towards a digital TMF standard. I am confident that Paul’s vision, expertise, and passion for innovation will ensure success."
Karen’s leadership has left a lasting legacy of progress and collaboration within the TMF community, and her contributions will continue to serve as a foundation for the committee’s future endeavors.
The TMF Reference Model Steering Committee, under Paul’s leadership, will continue to prioritize standardization and innovation to enhance clinical trial efficiency and data integrity globally.
About CDISC
Clinical Data Interchange Standards Consortium (CDISC) creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the European Medicines Agency (EMA) and China National Medical Products Administration (NMPA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)3 global nonprofit charitable organization with thousands of partners, volunteers, and member organizations around the world.
