Blog Posts
What I Wish I Knew When I Started Working in TMF
Author: Misty Mathis TMF Support Analyst When I first stepped into the world of TMF nearly 15 years ago, I felt a mix of excitement and apprehension. It was the start of my career. I was learning so much at such a fast pace, and some days the TMF felt like a vast, intricate maze…
Read MoreWhen Regulators Embrace AI: What TMF Teams Should Know
AI Is Heating Up at FDA: What Elsa 4.0 and HALO Could Mean for the TMF Artificial intelligence is not taking the summer off. In May 2026, the U.S. Food and Drug Administration announced Elsa 4.0, an expanded version of its internal AI assistant, along with HALO, a centralized platform connecting more than 40 application…
Read MoreTMF University: Accredited TMF Training for Clinical Trial Professionals
TMF University: Build the Next Version of Your TMF Career Clinical trial teams are being asked to do more than manage TMF records. They are expected to understand the “why” behind TMF processes, support inspection readiness throughout the study lifecycle, and make decisions that strengthen quality, oversight, and accountability. That is where TMF University comes…
Read MoreTMF Trivia Showdown
Join our TMF Trivia Showdown, where you’ll test your TMF knowledge using real-world scenarios, outplay fellow professionals, and battle your way to the top of the leaderboard for serious bragging rights.
Read MoreCelebrating Clinical Trials Day: The Story Behind the TMF
Every May 20, the clinical research community pauses to recognize Clinical Trials Day, a global celebration of the people, processes, and progress that make medical advancement possible. The history of this day traces back to May 20, 1747, when James Lind, a surgeon in the British Royal Navy, began what is often considered one of…
Read MoreTMF Talks Series: Document QC Beyond the Checklist
TMF Talks is a live, interactive webinar series built around real questions from the TMF community. Pooja Brahmbhatt and Ben Rogers will discuss what meaningful QC looks like in practice, including how to document findings, trends, and follow up actions. Attendees will gain insight into how strong QC practices strengthen accountability and provide credible evidence of oversight when teams are questioned during inspections.
Read More8 Practical Next Steps for Stronger TMF Indexing
Based on the discussion in Practical TMF Indexing for Real World Scenarios featuring Janice del Rosario and Ben Rogers, here are eight practical steps teams can take next. 1. Confirm who owns the TMF index Make sure one person or group is responsible for leading updates, resolving ambiguity, and coordinating cross functional input. Shared responsibility…
Read MoreTMF Talks Series: Practical TMF Indexing for Real-World Scenarios
Janice del Rosario and Ben Rogers will share practical examples and decision-making approaches that help teams create consistent, defensible indexing across studies. The discussion will emphasize how clear indexing supports retrieval, oversight, and the ability to confidently explain TMF structure during audits and inspections.
Read MoreA Reminder of Why This Work Matters
This weekend, I drove two hours to visit my dad. I hadn’t seen him in a while, and he had just celebrated another birthday. As our parents get older, those visits start to mean a little more. We were sitting in the living room talking when he casually said, “Did you know I’ve had three…
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