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!
A regulatory binder is crucial for managing clinical trial documents, it ensures compliance with regulations, and makes audits easier. It helps keep important documents organized and readily accessible for trial monitors, auditors, and regulatory authorities, and serves as a useful reference for the research team. While it’s not legally required, maintaining a regulatory binder is […]
What aspects need validation to ensure confidence in AI-driven processes, and is it possible to achieve 100% certainty?
And here’s the twist – while iRenix was laser-focused on their operations and study start-up processes, we rolled up our sleeves to deliver a full-on, turn-key eTMF setup from scratch.
Periodic TMF reviews automatically documented. Quality and completeness under control!
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.