Compliance

The core of our being

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.

HIPAA, FDA 21 CFR 11, GCP, GDPR wordsearch

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.

Security shield

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


CSV and compliance diagram