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:
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:
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
We are excited to share that Flex Databases has been named a Top Clinical Management Provider for 2024 by Life Science Review. This prestigious recognition highlights our strong reputation and the trust placed in us by both customers and industry peers, reflected in numerous nominations from Life Science Review subscribers. This award comes at a […]
Clinical trials provide essential information on the safety and effectiveness of drugs. Sponsors ensure that investigators follow protocols and collect and report quality data. Quality in clinical trials means that the product or service meets applicable regulations and customer requirements. A Quality Management System (QMS) in clinical research ensures compliance with ethical, regulatory, and GxP […]
Metronomia, a leading Data Management and Biostatistics CRO in EU, has selected Flex Databases’ eTMF module to support one of its biotech clients. Simon Rückinger, Managing Director at Metronomia Clinical Research GmbH, explained their decision and what they expect from the partnership. “We needed a flexible and simple eTMF solution that could meet the specific […]
Clinical Data Management Systems (CDMS) and Clinical Trial Management Systems (CTMS) are two key tools that play crucial roles in this process. While they might sound similar, they serve distinct purposes and offer different functionalities. What is a Clinical Data Management System (CDMS)? A Clinical Data Management System (CDMS) is a specialised tool designed to […]
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.