Agatha Launches Automated Integration with Veeva eTMF

Streamlining Document Management to Strengthen the Global Competitiveness in Clinical Trials

Tokyo, Japan / Paris, France / Boston, USA - Agatha Inc. (Head Office: Chuo-ku, Tokyo; CEO: Chiemi Kamakura) announced the official release of a new automated integration feature between Agatha eISF and Veeva eTMF, available on December 1, 2025.

Co-developed with a leading global pharmaceutical company, this feature is designed to meet the practical needs of clinical operations while supporting international standards.

The new integration connects an industry-leading electronic trial master file (eTMF) system used by all of the world’s top 20 pharmaceutical companies, with Agatha, the leading document management platform used by over 400 life sciences companies worldwide, including hospitals, pharmaceutical companies, CROs, and Medtechs.

This new capability enables global clinical trial stakeholders to achieve greater efficiency, quality, and operational speed while enhancing both competitiveness in global clinical research and strengthening collaboration between sponsors and sites.

Background and Challenges

Across the life sciences industry, sponsors and sites face increasing pressure to improve the speed, quality, and consistency of clinical operations. Manual document transfers between systems frequently result in heavy workloads, higher risk of human error, and increased security concerns associated with local file storage.

At the same time, sites often need to create local procedures or guidance to manage documentation flows, creating operational variability and limiting standardization across regions.

To address these industry-wide challenges, Agatha has been expanding its ecosystem capabilities. In July 2025, the company released its first ecosystem feature: an AI-assisted document registration function. The newly released integration represents the second major step in this effort.

Previously, sponsors had to manually download clinical trial documents from internal eTMF and upload them to a site’s Agatha workspace, resulting in heavy workloads, a higher risk of human error, and increased security concerns related to local file storage.

On the site side, manual preparation of documentation rules and guidance created additional administrative burden, highlighting the urgent need for standardization and long-term operational efficiency.

Overview and Key Features

The new integration automatically transfers and stores clinical trial documents approved in the sponsor’s eTMF to the site’s Agatha workspace.

Agatha’s built-in AI automatically classifies documents into the correct folders and records transfer and approval histories. This design ensures full traceability and facilitates quality assurance and audit-readiness.

Furthermore, Agatha has adopted a folder structure aligned with the CDISC ISF Reference Model v1 (Draft), reflecting the latest standards as of October 2025. This alignment ensures standardized organization and storage of documents aligned with international norms, supporting data integrity and transparency in global clinical trials.

Key Benefits

Efficiency
Automatic transfer from eTMF to the site’s Agatha significantly reduces manual workload.
Quality
Automated tracking ensures complete visibility of submission and receipt histories, minimizing human error.
Security
Local storage is eliminated, reducing the risk of data breaches.
Standardization
Minimized need for site-specific manuals and explanations, ensuring consistent trial operations.

These improvements enable sponsors, hospitals, CROs, and SMOs to operate more efficiently on a unified platform, supporting harmonized workflows across regions.

Proof of Concept (PoC)

Prior to release, Agatha conducted a proof-of-concept study in October 2025 in collaboration with a leading global pharmaceutical company and two clinical sites. The PoC confirmed that both the integration feature and the CDISC-compliant folder structure are practically applicable in clinical site operations.

Future Developments

As the third phase of its Clinical Trial Ecosystem initiative, Agatha is currently developing a Single IRB support function. Agatha remains committed to supporting digital transformation across the life sciences industry, helping sponsors, hospitals, CROs, and SMOs work more efficiently and to fulfilling its mission of “delivering new medicines to patients faster and more safely.”

About Agatha Inc.

Agatha Inc. provides the cloud-based document management platform “Agatha” for sharing, managing, and archiving clinical and quality-related documents across the life sciences industry, including hospitals, pharmaceutical and medical device companies, CROs, SMOs, and testing organizations. Leveraging advanced technologies, Agatha enables higher quality, faster, and more efficient operations in clinical research and pharmaceutical manufacturing, contributing to the improvement of global health and medicine.

Media Contact

PR Office, Agatha Inc.
Attn: Marion Béhier
Email: [email protected]