The Trial Master File (TMF) has always been a cornerstone of clinical research, but with the FDA’s recent guidance on standardized electronic submissions for NDAs and BLAs, its importance has reached new heights. This guidance not only streamlines the submission process but also enhances inspection readiness, compliance, and data integrity. Let’s explore how these updates…

Webinar Recap: Insights from the CDISC and TMFUS Interchange Conference We kicked off with Cassandra Andrade, who warmly welcomed the attendees and introduced her co-hosts, Gillian Gittens and Ben Rogers. Cassandra acknowledged familiar faces from recent events, like the CEDA’s conference, underscoring the vibrant network joining this webinar. Ben Rogers shared critical takeaways from the…

Webinar Recap: TMF Quality Assurance and Auditing Practices In our Ensuring Excellence: TMF Quality Assurance and Auditing Practices webinar, Janice Del Rosario, Director of TMF Services at LMK Clinical Research, and Ruby Scott, Associate Director of TMF Services experienced – industry professional, led an insightful discussion on TMF quality assurance and auditing best practices. With…

Trial Master File (TMF) Management Resource Guide at Startup This resource guide outlines essential steps and best practices for effectively managing the Trial Master File (TMF) at the start of a clinical trial. It focuses on the early development of key documents, expectations for stakeholder collaboration, and ongoing quality control and metrics reporting. 1. Early…

Happy Halloween from the team at LMK! 🎃 We’ve been carving pumpkins, stashing away candy (some of which might actually make it to trick-or-treaters), and breaking out our best zombie moves every time “Thriller” starts up on our playlist. Halloween is spooky for many reasons, but here’s a frightening thought: Thriller came out nearly 35…

Quality assurance is at the core of every successful clinical trial, and the Trial Master File (TMF) is a crucial component of that process. A well-maintained TMF ensures compliance with regulatory requirements and keeps clinical trials inspection-ready at all times. Building a strong TMF quality assurance framework not only safeguards the integrity of a study…

As summer draws to a close and Labor Day signals the start of a new season, we find ourselves returning to familiar routines. You’ve gone through the steps before—whether it’s getting the Trial Master File (TMF) in order or preparing your kids for the school year ahead. Both tasks require the same attributes for success:…

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…