eTMF Resources

1. 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.

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. 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.

4. eTMF Systems Tell Compelling Story Of COVID-19 Vaccines 3/7/2022

   The rapid development of Covid-19 vaccines may lead more drug developers to increase their speed and agility by adopting electronic Trial Master File (eTMF) systems. In the case of Covid-19 vaccines, discover how eTMF systems tell a dramatic tale.

5. Paying Sites To Reduce Burden 6/12/2026

   Beth Harper and Rosie Filling discuss site burden, enrollment pressure, and why sponsors should help pay for technology and training.

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. Validation And Why Sponsors Say Yes 6/12/2026

   Joe Dustin explains why validation documentation and sponsor benefit are key to getting approval for site-system integration.

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 Standards Matter At Scale 6/12/2026

   Joe Dustin shows why custom integrations do not scale and why standards are essential for efficiently connecting many sites.

10. Understanding Security And Role-Based Access In An eTMF Platform 3/2/2023

    Most unauthorized data breaches enter through doors that already exist. Learn how role-based access can improve security by tailoring access to each user’s needs and responsibilities.