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

Testimony Agenus
Why Agenus Chose Flex Databases: A Client’s Perspective

October, 2024 – Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a strong pipeline of immune modulating antibodies, together with Flex Databases announce the successful implementation of Flex Databases’ Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) solutions, including a new AI-driven feature for automated document filing and metadata assignment. This partnership […]

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FDA guidance
FDA Releases Guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

In October 2024, the U.S. Food and Drug Administration issued a final guidance titled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers. https://www.fda.gov/media/166215/download    This guidance provides recommendations on the use of electronic systems, electronic records and electronic signatures in food, medical product, tobacco product, and new animal drug clinical investigations.  […]

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FGK Interview, Martin Krauss
Client Spotlight: FGK Clinical Research GmbH CRO’s Experience with Flex Database

We had the pleasure of sitting down with Martin Krauss, Co-Founder and Managing Director of FGK CRO, to discuss how Flex Databases has supported their clinical research operations over the past 3.5 years.In this interview, Martin shares: • Why FGK CRO initially chose to partner with Flex Databases.• How our CTMS, TMF, and LMS solutions have transformed […]

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product updates
Exciting Updates: Enhancements to Our Platform!

We are thrilled to share several key enhancements that will streamline your workflows and improve data management.  Enhanced Duplicates Search Our Duplicates Search feature has received a significant upgrade! The system now identifies 100% duplicate files from your Inbox by checksum, ensuring cleaner data management. When files are moved from the Inbox to any folder […]

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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.