eTMF Resources

  1. 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.

  2. Rewind The Clock And Take TMF Back To Basics 12/4/2023

    Consider the evolution of Trial Master Files (TMF) in clinical trials when tackling the paradigm of maintaining simplicity while embracing technology.

  3. 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.

  4. 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.

  5. How Real-Time eTMFs Are Helping Keep Trials On Track 3/2/2023

    Learn how real-time dashboards assist with the sorting of information so clinical trial and medical affairs teams know what needs to be done, when, and by whom.

  6. 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.

  7. 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.

  8. 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.

  9. Crowdsource UAT: An Opportunity For Future Validation 6/28/2023

    IQVIA, a leading health information technology and clinical research company, has introduced a new validation model for eTMF patterned after approaches used within the larger tech space.

  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.