eTMF Resources

  1. 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.

  2. eTMFs Uncovered: 5 Costly Misconceptions To Avoid 3/21/2025

    Critically examine prevalent myths surrounding electronic Trial Master Files (eTMFs) and their integration with electronic Investigator Site Files (eISFs).

  3. Why Sponsors And CROs Are Racing To Implement A Connected eTMF-CTMS 8/30/2022

    A must for all clinical leaders, this webinar shares strategic, operational, regulatory, and financial benefits of a seamless CTMS and eTMF integration. Watch the webinar to find out why CTMS-eTMF integration has increasingly become imperative for sponsors and CROs around the world.

  4. 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.

  5. 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.

  6. Transforming Field Rep Success 2/6/2025

    As the healthcare landscape evolves, maintaining accurate and timely information delivery becomes vital for building strong HCP relationships and improving patient outcomes.

  7. Secrets To A Collaborative Model To Improve TMF Management 10/30/2023

    Speakers from Phlexglobal and Regeneron share the benefits of their highly effective partnering model and lessons learned that you can apply in your organization.

  8. 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.

  9. How Real-Time eTMFs Are Helping Keep Trials On Track 3/2/2023

    Learn how real-time dashboards assist with the sorting of information so clinical trial and medical affairs teams know what needs to be done, when, and by whom.

  10. EU Annex 11: How To Stay Compliant 11/16/2022

    EU Annex 11 lays out the European Union’s regulations for using computerized systems during clinical trials. Learn how sponsors and sites seeking treatment approval in the EU must follow Annex 11.