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

Jan 18, 2024

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 bd@flexdatabases.com

More about our eTMF

TMF Quality Review 2.0 

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

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

Flex Databases offers a solution for all your archiving needs.

Learn more
WSG selected Flex Databases eTMF & CTMS to centralize and optimize study management

WSG selected Flex Databases eTMF & CTMS to centralize and optimize study management.

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RWE-ready eTMF for 24/7 transparency in your documents

To make everyone’s lives easier, we added a template for RWS to our eTMF – you can select it when you create an eTMF structure for the project from the list of default templates. 

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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.