Many questions arise about Brexit, and whoever works in the clinical trials industry in the UK or with the UK are having many concerns now – nothing is clear about the final conditions.
Here is a clarification of the most frequent concerns and how Flex Databases fixes them:
In any Brexit case, we, as a provider, and our clients will still be compliant with existing regulations. We are sure it won’t take both sides a lot of time to adapt to new ones when there are any announced.
As a global company, we provide software to customers all over the world, who report to many regulators and follow different laws. We follow:
To ensure and evidence regulatory compliance, we perform system validation during the whole development lifecycle of each new version and complete Compliance Assessments. Our validation methodology is based on GAMP® 5 guidance.
The release of every new system version comes along with updated validation documents according to the risk-based approach proclaimed by industry standards.
2. Data storage
With any Brexit scenario, we can offer a suitable location for secure data storage.
Flex Databases system is cloud-based, and all the data is stored on servers in various Data Centers in different countries. We have a list of approved Data Centers according to our SOPs, and location of servers and backups are agreed and reflected in the Service Level Agreement. Generally, Data Center location depends on the Client’s requirement.
3. Data protection
Eight years of being a part of the global clinical trials industry help us to pre-solve some of the issues such a comprehensive process as Brexit may bring. We are prepared to act fast and efficient when the final deal or no-deal conditions are given and make everything the best way for our customers.
Our security policy allows us to adhere to the following standards and regulations, demonstrating our commitment to customers’ security and privacy:
To know more, check out our Data Protection Statement and Data Protection Considerations.
Do you have any other concerns considering picking an eClinical system during or after Brexit? Share it with us through contact@flexdatabases.com – we will be glad to answer them!
Late November we’ve hosted a joint webinar with Deloitte on how you can and why you should consider digitalizing Quality Management System.
What’s usually been a whole collection of different graphs is now in one – and you can see when and if something goes wrong.
Flex Databases DMS is done exactly right – and here’s a quick overview of manager & user processes, that get simply better with its implementation.
WSG selected Flex Databases eTMF & CTMS to centralize and optimize study management.
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.