eTMF Resources

1. Overcoming 5 Challenges Of Implementing eClinical Technologies 6/26/2023

   Assess five common pitfalls trial teams face when incorporating new technology and identify potential solutions to mitigate the common risks.

2. The TMF Trifecta: Finding Balance In An Era Of Constant Change 7/1/2022

   In this article, discover TMF through the operational framework of people, process, and technology and how these factors affect stakeholders.

3. 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.

4. How eTMF Can Improve Global Clinical Trials 3/30/2026

   Without the right systems, global trial documentation adds risk. Centralized digital workflows improve visibility, audit readiness, and keep teams aligned, compliant, and efficient.

5. 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.

6. A Model For Improving TMF Management 10/30/2023

   Get pragmatic details of what it took to build a successful partnership, why it has become a model for other departments within Regeneron, and lessons learned you can apply in your organization.

7. 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.

8. eTMF For Clinical Trial Master Files And Operations 3/2/2022

   This video shows how a modern eTMF system built with a new exchange standard promises to bring better collaboration and compliance.

9. Why An eTMF? It's Time For A Specialized Digital Solution 3/3/2023

   Clinical trials generate reams of documents. Use an electronic trial master file to streamline much of the work of document management, logging, and compliance.

10. Site Tech, Integration, And Reducing Burden 6/12/2026

    Beth Harper, Rosie Filling, and Joe Dustin discuss site tech, integration, and how sponsors can reduce burden while improving flow.