Agatha

Agatha provides a comprehensive suite of applications tailored for the life sciences sector, facilitating efficient document management, clinical study structuring, and quality process security. With a global presence in Boston, Tokyo, and Lyon, Agatha supports over 400 life science companies and 60,000 users worldwide.

Agatha's solutions enable centralized management of documents related to Clinical Operations, Quality Management, and Regulatory Submissions. This streamlines the processes of creation, sharing, review, approval, and storage, enhancing both security and efficiency.

Organizations can transition to a fully digital and paperless system with Agatha, which reduces workload while bolstering data security. The platform ensures compliance with regulatory standards and streamlines workflows.

Agatha's cloud-based document management system is designed to meet global regulatory requirements, including FDA CFR 21 Part 11, GDPR, and EU Annex 11. It offers a secure and efficient platform for managing documents and ensuring compliance across international and domestic operations.