Archiving eTMF for 25 years? Secure, accessible, and compliant with Flex Databases 

Jan 18, 2024
Archiving eTMF for 25 years

Good Clinical Practice guidelines require clinical trial documents to be kept for at least two years after the last marketing application approval in an ICH region. These documents may need to be stored longer if regulations or the sponsor require it.

The EU Clinical Trial Regulation (CTR) 536/2014 demands that the content of the clinical trial master file be archived for a minimum of 25 years after the trial ends. This ensures compliance with new regulations and helps preserve important data for future research and checks.
The main challenge is managing and storing large amounts of data effectively, ensuring it’s easy to retrieve and complies with strict regulatory standards. You should keep it locked for editing, but accessible.

Flex Databases offers a solution for these archiving needs. It’s a secure, compliant, and user-friendly system that helps organize and store all trial documents easily and securely.

The advantages of using Flex Databases for long-term archiving include:

  • Regulatory Compliance: we keep data in line with industry standards
  • Data Integrity: we preserve the authenticity and accuracy of clinical trial data over decades
  • Cost Efficiency: lowers costs related to physical storage and IT infrastructure
  • Security: utilizes advanced encryption and access control to protect sensitive trial data
  • Accessibility: enables quick data access for audits, verification, and research

We don’t just meet regulatory requirements; we help you maintain compliance and be ready to demonstrate that you are compliant in the event of inspections in the most efficient way.

If you want to learn more about Flex Databases eTMF – send us a request via the form on top of the page or reach out to

More about our eTMF

Stallergenes Greer logo
Stallergenes Greer Chooses Flex Databases eTMF to Enhance Inspection Readiness and Oversight Efforts

Stallergenes Greer, a global healthcare company specializing in allergy diagnosis and treatment through allergy immunotherapy (AIT) products, has chosen Flex Databases as its eTMF vendor. The answers were provided by Virginie Lobrégat-Duriez, Director of Clinical Operations, and Dominique Jouny, Senior Clinical Project Manager. Q1. What did Stallergenes Greer have to start looking for an eTMF […]

Learn more
how we implenented eTMF
How we implemented eTMF & developed SOPs in 3 weeks for iRenix

And here’s the twist – while iRenix was laser-focused on their operations and study start-up processes, we rolled up our sleeves to deliver a full-on, turn-key eTMF setup from scratch.

Learn more
TMF Quality Review 2.0
TMF Quality Review 2.0 

Periodic TMF reviews automatically documented. Quality and completeness under control!

Learn more
Archiving eTMF for 25 years
Archiving eTMF for 25 years? Secure, accessible, and compliant with Flex Databases 

Flex Databases offers a solution for all your archiving needs.

Learn more

Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.