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
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Trial master files (TMFs) are essential for completing clinical studies, but managing TMF content can be very complex. Electronic trial master file (eTMF) systems represent the next step in clinical trial document management and are becoming an integral part of future clinical research. What is an eTMF? An electronic trial master file (eTMF) is a […]
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Effective site selection and management are critical components of successful clinical trials. Choosing the right locations and overseeing their operations can significantly impact the trial’s timeline, budget, and ultimately, its success in delivering reliable data. This article explores essential strategies for optimizing site selection and management, highlighting key considerations, practical tips, and the role of […]
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.