Compliance

The core of our being

Compliance

Regulations. By Design.

Encapsia is designed on a basis of industry leading expertise and knowledge of world-wide regulatory requirements relating to the use of eClinical, eSource and cloud-based clinical data systems.

This expertise is the foundation of each encapsia component and is woven throughout the software development lifecycle to ensure key regulations including FDA 21 CFR 11, GCP E6(R2), GDPR, HIPAA and Data Integrity are fully and demonstrably supported.

Security. Best in class.

Information security is assured by use of top-tier, ISO27001 certified cloud hosting centres in customer definable geographies. This ensures support of both international and local data protection and privacy laws (‘Privacy by Design’) for any study.

Best in class security technology is employed throughout development and deployment including penetration testing, vulnerability and code scanning, robustly managed through specific governance processes.

This, combined with the highly qualified and experienced technical staff result in a clinical data system that conforms to the most exacting of international regulatory standards.

Compliance
Compliance

Encapsia frees you to take advantage of new paradigms of trial management to increase your team’s efficiency and profitability, without compliance concerns.

Latest articles

Digital transformation can happen for any sponsor: How small and mid-sized biopharmaceutical companies can easily achieve digital innovation for their clinical data

In just a couple of decades, information technology has undergone a radical transformation –a sweeping evolution from floppy drives to data warehouses to data lakes. Our industry has unfortunately not ridden the arc of technology at the pace of other…

Read article

A better way to drive your digital transformation

As the ways in which clinical trials are conducted and monitored continue to modernize at pace, there is an urgent need for digital transformation in the industry. If sponsors are to realize their goals of running flexible, decentralized trials (DCT),…

Read article

Five predictions for the future of decentralized clinical trials

The message was clear from industry leaders last year – today’s clinical trials need decentralized solutions. More complexity means intensive data capture and continuous flows are essential, and vital strategic decisions rely on real-time data analysis and intelligence. Existing point…

Read article