Clinical Trials Data Security

Flex Databases Security Policy Overview

Flex Databases Platform is designed to help our Clients to work securely with their data and deliver it to users, customers, and partners, and to drive better business outcomes. Flex Databases protects Clients’ data, ensure the following security regulations, and mitigates all potential risk which is essential to building trust and delivering the high level of service. Flex Databases takes a risk-based approach to security, and this page details the measures and technologies implemented to protect our customers.

Our security implementation allows us to adhere to the following standards and best practices, demonstrating our commitment to customers’ security and privacy:

  • 21 CFR Part 11
  • HIPAA
  • GDPR

As a SaaS provider Flex Databases pays great attention to the safety of the data on all levels. We use only the best scenarios and industry practices to keep and protect customers’ data: from physical security at the data centers to full control using audit trail at the data level:

  • Processes (SOPs, IQs, PQs, WPs)
  • Physical
  • Infrastructure
  • Virtual environment
  • Application
  • User
  • Data

We have a strict backup policy:

To maintain a robust disaster recovery strategy, backups are retained at separate Flex Databases data centers at a geographically different location within the same region as the primary data center, with the same level of physical and infrastructure security described above, to maintain a robust disaster recovery strategy. All backups are encrypted-in-transit to the separate data center and are encrypted-at-rest while stored at that location. We are in the total charge for the security of data; that’s why we use the best experience in data storage and backup technology.

  • We use GFS (grandfather-father-son) rotation strategy.
  • We do an incremental backup of all client’s data two times per day, including weekends.
  • We perform FULL back up every day, including weekends.
  • We keep data for the last two weeks, for the previous two weeks, per each month of the year and per each year all the time.

If you have any questions, regarding our security policy or any other questions, send us an e-mail at contact@flexdatabases.com

Blog

AI eTMF Webinar
Webinar with Deloitte | AI in eTMF – Auto-Classification and Metadata: Efficiency and Compliance

Join us for an exclusive insightful webinar as we explore Artificial Intelligence (AI) within the Electronic Trial Master File (eTMF) system. Explore how AI can transform document management, simplify processes, and maintain compliance with regulatory standards. What to Expect? Have burning questions about AI implementation in eTMF? This webinar offers the perfect opportunity to have […]

Learn more
AI validation for life sciences – a unique challenge of dynamic nature

What aspects need validation to ensure confidence in AI-driven processes, and is it possible to achieve 100% certainty?

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
Deloitte and Flex Databases
Deloitte and Flex Databases forge strategic alliance to drive digitalisation in Life Sciences across Europe

This collaboration is set to transform the Life Sciences sector by leveraging Deloitte’s expertise in process management, validation, onboarding, and consulting, alongside Flex Databases’ state-of-the-art electronic systems.

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.