What are the main concerns of choosing CTMS and TMF during Brexit and how Flex Databases fixes them?

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:

1. Regulatory alignment

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:

• ICH Good Clinical Practice as our main guideline

• FDA 21 CFR Part 11

• EudraLex Vol. 4 GMP Annex 11

• Guideline on the content, management and archiving of the clinical trial master file Good Manufacturing Practice

• Good Pharmacovigilance Practice

• etc.

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:

• 21 CFR Part 11

• HIPAA

• GDPR

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!