Posts by Isaiah Howard

Establishing and maintaining a robust Trial Master File (TMF) is akin to crafting the blueprint for success in clinical trial management. It serves as the cornerstone, holding together the intricate web of documents, protocols, and data that underpin the entire trial process. However, constructing a TMF that not only meets regulatory standards but also exudes…

The Paris 2024 Olympics are set to captivate the world with a flurry of inspiring headlines: Kelly Cheng and Sara Hughes Chase Olympic Gold in Beach Volleyball: After reuniting in 2022 and winning the world championship, this duo is now a top contender for Olympic gold​ Bradly Sinden (Taekwondo): A silver medalist in Tokyo, Sinden…

The FDA’s recently released draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” outlines essential requirements for increasing diversity in clinical trials. While the primary focus is on promoting inclusivity, several elements are directly relevant to the Trial Master File (TMF). This article highlights the critical aspects that…

When managing a clinical trial, the Trial Master File (TMF) plays a critical role in ensuring the trial’s success. To effectively manage the TMF, it is essential to track and monitor key metrics and KPIs that measure the completeness, accuracy, accessibility, and compliance of the TMF with regulatory guidelines. Here are five new tips to…

Introduction: The life sciences industry is experiencing a rapid expansion in clinical research, accompanied by increasing complexity in trial operations. This growth, however, is hindered by a critical challenge: a widespread Trial Master File (TMF) skills gap. The shortage of skilled TMF professionals is leading to a rise in TMF-related inspection findings, which pose a…