eTMF Resources

1. Electronic Trial Master File: The Metrics 3/13/2023

   Here, the author defines several key ideas surrounding data, reports, and insights, honing in on one that is uniquely electronic and only possible because of the move to eTMF — Metrics!

2. Achieving Faster, Simpler Validation Through Crowdsource UAT 6/28/2023

   An approach most often seen in the larger tech space, crowdsource UAT can offer several potential advantages for the clinical trial industry and eTMF validation.

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. 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.

5. 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.

6. 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.

7. Build Versus Buy: What's The Best Tech Tool For Study Activation? 5/11/2023

   In the case of study activation, there are several compelling reasons that buying an appropriate purpose-built system is a better choice than taking on the challenge of building a study activation tool.

8. 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.

9. Improving Quality And Efficiency In TMF Document Processing 10/19/2023

   By adhering to the principles outlined in this article, learn how teams can be better enabled to carry out efficient, high-quality processing of documents throughout the entirety of a study.

10. Examining The "Why" And "How" Of Integrating Your eTMF And CTMS 6/24/2022

    As requirements for improved inspection readiness and quality risk management become more critical, discover the need to create a seamless integration and data flow between the eTMF and CTMS.