eTMF Resources

1. 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.

2. A Model For Improving TMF Management 10/30/2023

   Get pragmatic details of what it took to build a successful partnership, why it has become a model for other departments within Regeneron, and lessons learned you can apply in your organization.

3. 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. 

4. 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.

5. 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.

6. The Race To Implement A Connected eTMF-CTMS 5/25/2023

   Sponsors and CROs are becoming more dependent on CTMS-eTMF integration. Watch as experts examine the operational, regulatory, and financial advantages of this integrated technology.

7. Mastering Scientific Communication Plans Within Medical Affairs 2/6/2025

   Join industry leaders from Anju and 9 Labs for a presentation on the pivotal role of Strategic Communication Plans (SCP) in medical affairs.

8. Advanced Analytics To Power Action Across The Trial Continuum 10/18/2023

   Examine how Medidata's Clinical Operations solutions are working to improve the efficiency of study timelines through their platform, guided by interconnected workflows and data-driven insights.

9. 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.

10. 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.