Data Protection Considerations

Version of 30 April 2018

Flex Databases provides software solutions that support clinical trials conduction at all stages and one of our main priorities is confidentiality and integrity of our customers’ data. Flex Databases is concerned about data protection and privacy issues. Flex Databases protects customers’ data, ensures following the security regulations, and mitigates all potential risks which are essential to building trust and delivering the high-level of service.

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

  • 21 CFR Part 11
  • HIPAA
  • GDPR

In terms of GDPR Flex Databases is the data processor, and the Company’s customers are the data controllers. Controllers are responsible for determining what data is to be collected and processors are involved in the data processing. Only customers decide which data is collected and how it is processed and stored. Flex Databases strictly fulfills the agreements with the customers and ensures that data is processed following the instructions by data controller.

Flex Databases provides to our customers the tools that allow to meet their data controller responsibilities under the GDPR. The examples of such tools are: 

  • tools for data pseudonymization
  • strong control of the system access rights
  • tool for data download at the sites at the end of the study
  • all traffic into and out of the Flex Databases Platform is encrypted using TLS/SSL protocol that leverages either SHA-2 or AES algorithms
  • all access to the user interfaces is encrypted via HTTPS/SSL

Flex Databases System is a modular-structured platform which is provided for customer use based on contractual obligations as a web-based system which includes the purchased module set that is specific for each customer. Standardly Flex Databases System is provided as ‘Software as a Service’ (SaaS) which is a software distribution model in which System supplier (Flex Databases) hosts applications and makes them available to customers cloud-based over the Internet.

Cloud-based means that storage and processing take place on servers hosted by Flex Databases in subcontracted data centers which are evaluated before contracting in accordance with the SOP-QA-011 ‘Purchasing and Vendor Assessment’.

Management of all personal data is designed in line with the requirements of data protection regulations. We store the data of our European clients in the qualified data centers located in the EU.

The appointed Data Protection Officer trains the staff in the GDPR and provides guidance on the related issues. In case of any data privacy concerns please contact: dl_privacy@flexdatabases.com

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