Article | December 5, 2023

A Blueprint For Genuine Partnership In TMF Improvement

By Joanne Malia and Janice Cassamajor


The Trial Master File (TMF) has transitioned from a post-study document repository to a pivotal element in the regulatory journey, prompting a shift in perspective for some companies. Rather than viewing it merely as a compliance obligation, the TMF is now recognized as a valuable company asset, emphasizing the importance of its meticulous maintenance and management.

While some firms maintain a dedicated TMF team, others opt for support from Contract Research Organizations (CROs), understanding that the quality of this collaboration holds the potential to not only enhance the TMF but also fortify key areas within each partner organization. In their collaborative white paper, titled "The Regeneron-Phlexglobal Collaborative Model for TMF Continuous Quality Improvement," Regeneron and Phlexglobal unveil a blueprint for a robust partnership founded on trust, openness, and genuine collaboration.

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