Agatha

Agatha Corporation is a cloud-based document and quality management platform purpose-built for the life sciences sector. With offices in Boston, Tokyo, and Lyon, Agatha supports over 400 life sciences companies and 60,000 users globally, helping them optimize document management, structure clinical studies, and secure quality processes. The platform is designed to be efficient, user-friendly, and fully compliant with key international regulations.

Agatha serves a broad range of life sciences organizations, including biotechs at every stage of growth, pharmaceutical companies, medical device manufacturers, contract research organizations (CROs), and healthcare providers. Its suite of applications addresses clinical operations, quality management, and regulatory submissions, enabling organizations to transition to fully digital, paperless workflows while maintaining rigorous compliance standards.

Core Applications

• Agatha eTMF: Inspection-ready management of essential Trial Master File (TMF) documents and records, supporting clinical operations for pharma companies, biotechs, CROs, and healthcare organizations.
• Agatha Remote ISF: Management of clinical site documents and associated processes, designed for pharmaceutical and healthcare use cases.
• Agatha SOP: Supports the creation, review, and approval of standard operating procedures (SOPs) as well as employee training records, applicable across biotech, medical device, pharma, and CRO sectors.
• Agatha Quality: Quality document and process management covering CAPAs (Corrective and Preventive Actions), deviations, and change controls, serving all major life sciences verticals.
• Agatha Regulatory: Creation, storage, and management of regulatory documents, supporting biotech, medical device, pharma, and CRO organizations in their regulatory submissions and compliance activities.

Core Capabilities

• Centralized Document and Process Management: Agatha enables centralized management of clinical operations, quality management, and regulatory submissions-related documents, streamlining the entire lifecycle including creation, sharing, review, approval, and storage.
• Paperless Operations and Enhanced Security: Agatha enables organizations to transition to a fully digital and paperless system, reducing administrative workload while strengthening data security and streamlining workflows.
• Global Regulatory Compliance: The platform is designed for both international and domestic operations, meeting global regulatory requirements including FDA 21 CFR Part 11, GDPR, EU Annex 11, and Japan's ER/ES Guidelines, providing a secure and efficient environment for document management and compliance assurance.
• AI-Powered Document Assistant: Agatha has introduced an AI-powered document assistant to further enhance document management efficiency and user productivity.

Notable Achievements and Recognition

• Recipient of the Best of GCP Expert Award 2026, recognizing excellence in Good Clinical Practice.
• Named in the Technology Fast 50 Japan 2025, highlighting rapid growth and innovation in the Japanese market.
• Partnered with Optos to drive clinical trial innovations using Agatha's eTMF solutions.
• Supports over 400 life sciences companies and 60,000 users across global markets.

Agatha's comprehensive suite of applications, combined with its commitment to regulatory compliance and operational efficiency, makes it a trusted partner for life sciences organizations seeking to modernize and secure their document and quality management processes on a global scale.