eTMF Resources

1. A Checklist For Good TMF Health 10/16/2023

   The Trial Master File serves as the central repository of documentation. Utilize this guide to better concentrate on critical considerations and safeguard the well-being of your TMF.

2. 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.

3. How eTMF Can Improve Global Clinical Trials 3/30/2026

   Without the right systems, global trial documentation adds risk. Centralized digital workflows improve visibility, audit readiness, and keep teams aligned, compliant, and efficient.

4. 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.

5. 5 Features to Look for in Your Next eTMF 3/2/2023

   Not every electronic trial master file will provide the robust support and compliance measures required. When searching for a successful solution, make sure the eTMF of interest has these five features.

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. 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.

8. 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.

9. 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.

10. More Than Document Collection: The eTMF As The Conductor Of Study Start-Up Part 1 – Site ID And Selection 3/23/2022

    In this post, gain insight into how the eTMF can mitigate the main drivers of delay in the site ID and Selection process.