Posts by Isaiah Howard

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:…