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. 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.

  3. 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.

  4. 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.

  5. 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. 

  6. 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.

  7. Checklist: Essential Features Of A Future-Proof Automated eTMF System 3/2/2022

    During evaluation of eTMF systems, use this information to ensure your selection will deliver complete, timely, and high quality TMFs now and in the future.

  8. 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.

  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. 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.