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

January 18, 2024

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

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.

Blog

June 5, 2025
We Are Hiring: System Analyst

We are driven by our high mission to make an impact in the Life Sciences industry. We provide flexible e-Clinical software systems for Clinical Research Organizations (CROs) and pharmaceutical companies. We work globally with clients all over the world, with our own offices located in the Czech Republic, Switzerland, Turkey, and the US.  Key responsibilities: […]

We Are Hiring: ASP.NET Developer

The Flex Databases team is seeking an ASP.NET Developer to join one of our Software Development teams. Our product is a SaaS eClinical platform designed for managing clinical trials and various business processes in the pharmaceutical industry. Our clients include biotech and pharmaceutical companies, as well as Contract Research Organizations (CROs) that outsource clinical trial […]

We Are Hiring: eClinical Product Trainer

At Flex Databases, we’re on a mission to make a real impact in the Life Sciences industry with our CTMS, eTMF, and other systems for Life Sciences. Our platform supports Clinical Research Organizations and pharmaceutical companies across the globe in managing the complex world of clinical trials with greater clarity and efficiency. Now, we’re looking […]

We Are Hiring: Associate Project Manager

📍Required location: Prague 💼Associate Project Manager Flex Databases is looking for an Associate Project Manager to join our Customer Success Management team, based in our Prague office. While this role can be fully remote within Czechia, you must be available to visit the office for occasional client meetings. Required location: Prague Fluency in German is […]

Contact us

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.