eTMF Resources

31. 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.

32. 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.

33. Let's Talk About The TMF Trinity 11/14/2022

    Explore the three things that all studies try to achieve with their trial master file, and how the accelerated usage of the eTMF helps to both manage and meet these expectations.

34. How To Reduce Risk And Effort When Migrating A TMF 10/19/2023

    Utilize this summary of key tips, checklists, and lessons learned to mitigate the risks and efforts associated with migrating a trial master file.

35. 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.

36. 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.

37. 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.

38. 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. 

39. 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!

40. 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.