Agatha Surpasses 90,000 Users Worldwide, Reinforcing Its Growing Presence in the Global Life Sciences Industry
The life sciences software company continues to expand the adoption of its cloud-based platform, supporting clinical research, quality management, and regulatory operations worldwide.
Agatha Inc. (Headquarters: Tokyo, Japan; President and CEO: Chiemi Kamakura; hereinafter referred to as "Agatha"), a provider of cloud-based document and process management solutions for the life sciences industry, today announced that its platform has surpassed 90,000 users worldwide, marking another milestone in the company's international development.
Following the announcement of 80,000 users earlier in 2026, this new milestone reflects the continued adoption of Agatha by organizations seeking to digitalize and manage their clinical, quality, and regulatory operations.
Across the life sciences industry, organizations are increasingly adopting digital solutions to manage growing volumes of documentation, coordinate activities across teams and locations, and meet regulatory requirements. Agatha supports this transition by providing a cloud-based platform designed to simplify document management, reduce administrative workloads, and facilitate collaboration across clinical, quality, and regulatory operations.
Supporting Life Sciences Organizations Across the World
Life sciences organizations face increasing demands when managing documentation, coordinating activities across teams and locations, and maintaining compliance with regulatory requirements.
Clinical research teams must manage essential trial documents, coordinate information between sponsors and investigative sites, and prepare documentation for audits and inspections. At the same time, quality and regulatory teams need reliable systems to manage controlled documents, approval processes, training records, and regulatory submissions.
Agatha addresses these requirements through a cloud-based platform supporting three main operational areas:
Clinical Operations: Solutions including eTMF, eISF, and CTMS to support clinical trial documentation, study oversight, and collaboration between sponsors, CROs, and research sites.
Quality Management: Electronic Quality Management Solutions (eQMS) for SOPs, training records, deviations, CAPAs and change control processes.
Regulatory Operations: Document management capabilities supporting the preparation, organization and management of regulatory documentation
Through these applications, organizations can replace fragmented document exchanges and paper-based procedures with structured digital processes, while maintaining traceability and control over their documentation.
Academic Research Demonstrates the Operational Benefits of Document Digitization
In July 2026, a research paper examining the effects of digitizing clinical trial-related documents and user satisfaction was published in the journal of the Japanese Society of Clinical Trials and Research. The study was funded by Agatha and analyzed survey results collected in 2023 and 2024.
Among 95 medical institutions that had implemented document digitization, 93.7% reported reduced physical storage requirements, 51.6% reported easier document retrieval, and 41.1% reported reduced working hours as benefits of digitization.
The study also found that institutions that had been using digital document management for one year or longer reported higher satisfaction levels than those with less than one year of experience.
These findings suggest that digitizing clinical trial-related documents goes beyond simply replacing paper with electronic files and has the potential to reduce administrative workloads at clinical trial sites.
Note: This study examined the effects of digitizing clinical trial-related documents in general and did not specifically evaluate the effectiveness of Agatha as an individual product.
Research Paper:
Journal of the Japanese Society of Clinical Trials and Research, Vol. 31 (2026)
https://www.jstage.jst.go.jp/article/jjsctr/31/0/31_1/_article/-char/ja/
Beyond Document Digitization: The Next Stage of Clinical Trial Management Through Multinational Collaboration and AI
Clinical trial document management is gradually evolving beyond the digitization of paper documents toward the optimization of entire operational workflows.
As the need to participate in multinational clinical trials continues to grow, it is becoming increasingly important to establish environments that enable seamless collaboration among medical institutions, pharmaceutical companies, contract research organizations (CROs), site management organizations (SMOs), and other stakeholders involved in clinical trials.
Furthermore, the next stage of clinical trial document management will involve not only storing documents and data electronically but also leveraging these digital assets effectively and utilizing technologies such as artificial intelligence (AI) to streamline operations.
In addition to digitizing document management, Agatha is advancing the broader digital transformation of clinical trial operations by providing functions that facilitate collaboration between medical institutions and clinical trial sponsors, as well as AI-powered capabilities that improve the efficiency of document registration processes.
Agatha will continue working to reduce the administrative burden on clinical trial professionals and create an environment that enables smoother collaboration among stakeholders worldwide, thereby contributing to the international competitiveness of the clinical trial ecosystem.
Comment from Chiemi Kamakura, President and CEO of Agatha Inc.
"Reaching 90,000 users worldwide is an important milestone for Agatha and a reflection of the trust placed in us by life sciences professionals across different countries and organizations.
Since our founding, we have worked closely with our customers to understand the challenges they face in managing clinical research, quality processes, and regulatory documentation.
As Agatha continues to grow internationally, we remain committed to developing practical solutions that help our customers manage their daily operations, collaborate across teams, and maintain the high standards required in the life sciences industry.
I would like to thank our customers, partners, and teams around the world for their continued trust and contribution to Agatha's development."
About Agatha Inc.
Agatha provides a cloud-based platform for document and process management across clinical research, quality management, and regulatory operations , to medical institutions, pharmaceutical companies, medical device manufacturers, contract research organizations (CROs), site management organizations (SMOs), clinical testing laboratories, and other organizations.
The company supports improvements in quality, speed, and efficiency across clinical trials, clinical research, and manufacturing operations. By leveraging advanced technologies to build systems and infrastructure that facilitate the development of new treatments and medicines, Agatha aims to contribute to healthier lives for people around the world.
Company: Agatha Inc.
President and CEO: Chiemi Kamakura
Address: WeWork, 9F Kabuto One, 7-1 Nihonbashi Kabutocho, Chuo-ku, Tokyo 103-0026, Japan
European Subsidiary: 132 rue Bossuet, 69006 Lyon, France
Capital: JPY 1.094 billion (including capital reserve)
Established: October 2, 2015
Website: https://www.en.agathalife.com/