eTMF Resources

1. A Checklist For Good TMF Health 10/16/2023

   The Trial Master File serves as the central repository of documentation. Utilize this guide to better concentrate on critical considerations and safeguard the well-being of your TMF.

2. Industry-First eTMF AI: PhlexTMF v21 4/6/2023

   Pre-trained on millions of documents and embedding the cumulative guidance of Phlexglobal’s TMF experts, uncover how teams can ensure clinical documents are “right-first-time” at document upload.

3. Running Your Trial In Your eTMF 3/13/2023

   Discover how people are part of the electronic Trial Master File trifecta and what to consider when implementing an eTMF in clinical studies.

4. Top 10 Questions For Selecting The Best eTMF System 4/11/2022

   An eTMF system can help Clinical Operations professionals manage the deluge of documents and data, but what capabilities are right for your situation? What is the best way to make the move to a modern eTMF from paper, spreadsheet trackers, or legacy tech to a new eTMF? Hear answers to these questions and more from a fellow Clinical Operations leader with experience in making the transition to an eTMF built for today's research ecosystems.

5. Discover The Value Your eTMF Should Deliver 3/7/2022

   A well-prepared Trial Master File (TMF) is critical to the success of any clinical trial. Because the TMF tells the whole story of a study – including every data point collected and decision made – managing it throughout the course of the trial is challenging.

6. 3 Key Functions Your eTMF Needs To Meet New EMA Regulations 6/23/2022

   The European Union Clinical Trial Regulation No. 536/2014 recently introduced the most significant changes to the processes for clinical trial applications in at least the past 15 years. Learn how this impacts the Trial Master File and consider three key functions that an electronic TMF must have to achieve compliance and maintain organizational success.

7. Why Your eTMF Needs Role-Based Access 3/2/2023

   Discover how role-based access controls can offer a way for clinical teams to answer the tough questions from regulators, investors, and other parties.

8. More Than Document Collection: The eTMF As The Conductor Of Study Start-Up Part 1 – Site ID And Selection 3/23/2022

   In this post, gain insight into how the eTMF can mitigate the main drivers of delay in the site ID and Selection process.

9. The eTMF As A Regulatory Standard 6/1/2023

   Discover essential insights on maintaining a high-quality Trial Master File (TMF) in a discussion about ICH GCP Essential Documents and the different regulations that apply to the TMF.

10. CDISC TMF Interchange Takeaways 10/16/2023

    Follow along as experts discuss reference models for Trial Master Files in clinical studies at the Clinical Data Interchange Standards Consortium's 2023 U.S. Interchange.