eTMF Resources

1. Ensuring Timeliness, Completeness, And Quality With Digital Solutions 12/13/2024

   A well-maintained TMF, supported by digital solutions, is the backbone of successful clinical trials, improving trial management and readiness for audits or regulatory submissions.

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. 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.

4. 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.

5. 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!

6. 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. 

7. 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.

8. Biocon's Rashika Suri Improves Approach To Managing Trial Master Files 3/7/2022

   Biocon is India’s largest biopharmaceutical company and an early adopter of the LifeSphere eTMF system. Rashika Suri, Head of Clinical Quality and Compliance at Biocon, discusses the importance of collaboration when implementing new technology.

9. 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.

10. 7 Key Findings From A Clinical Trial Operations Technology Survey 1/19/2022

    To stay competitive in the clinical research field, sites, sponsors, and CROs need to invest in remote technology. Discover seven key trends that your clinical trial team needs to know about.