Agatha Selected for METI’s FY2025 Supplementary Budget Program for a Demonstration Project in India to Develop a Standardized Clinical Trial Platform for Global South Markets

Agatha Inc. (Headquarters: Chuo-ku, Tokyo; President and CEO: Chiemi Kamakura; hereinafter “Agatha”) announced today that its project, “India / Demonstration Project for a Standardized Clinical Trial Platform for Global South Markets Supporting Multinational Clinical Trials, Starting with India,” has been selected for the Ministry of Economy, Trade and Industry (METI)’s FY2025 Supplementary Budget Program for Future-Oriented Co-Creation Projects in the Global South (Small-Scale Demonstration and Feasibility Study Program) as of September 21, 2026.

The selected project aims to adapt Agatha, a clinical trial digital transformation (DX) platform widely used in Japan, Europe and North America to local regulatory and operational requirements in India. Through the demonstration, Agatha will assess the platform’s effectiveness in improving the efficiency and quality of clinical trial operations, validate its business feasibility, and develop a scalable model for future expansion across Global South markets.

Official website for METI’s FY2025 Supplementary Budget Program for Future-Oriented Co-Creation Projects in the Global South (Small-Scale Demonstration and Feasibility Study Program):

https://r7h-gs-hojo-web-fspoc.jp/

Background and Overview of the Demonstration Project

As pharmaceutical development becomes increasingly global, multinational clinical trials are being conducted across a broader range of countries and regions. At the same time, many Global South countries, including India, continue to face challenges such as paper-based document management and fragmented operational processes across clinical trial sites. This has created a growing need for digital infrastructure that enables multinational clinical trials to be conducted efficiently and seamlessly.

Through the provision of the Agatha platform to medical institutions and pharmaceutical companies, Agatha has supported the digital transformation of clinical trial operations, including clinical trial document management, while accumulating extensive technical and operational expertise in Japan, Europe and North America’s clinical trial environment.

In this project, Agatha will combine this expertise with the DX implementation capabilities and business infrastructure of NTT DATA Japan Corporation (“NTT DATA”) to conduct demonstrations at local medical institutions and other relevant sites in India. By applying the platform to actual clinical trial operations, the project will evaluate the functions and operational processes required to support multinational clinical trials and seek to establish a sustainable model that can be continuously utilized in the local market.

Expected Benefits for Agatha

Through this project, Agatha aims to evolve the clinical trial DX infrastructure into a versatile platform aligned with international standards. By doing so, Agatha seeks to support international companies in conducting global pharmaceutical development more efficiently and seamlessly, while contributing to the international competitiveness of Japan-originated pharmaceuticals and medical technologies, as well as Japan’s healthcare industry as a whole.

Based on the results of the demonstration in India, Agatha will explore future business development and collaboration opportunities that leverage the respective strengths of Agatha and NTT DATA.

Comment from Chiemi Kamakura, President and CEO of Agatha Inc.

We are honored to have the opportunity to undertake this demonstration project in collaboration with NTT DATA. Agatha has worked closely with medical institutions and pharmaceutical companies to advance the digital transformation and operational efficiency of clinical trials and clinical research.

Combining the technologies and expertise we have developed in Japan with NTT DATA’s extensive DX capabilities and validating them in India’s rapidly growing market represents an important first step in accelerating our international business.

Through this project, we will first establish an operational model optimized for the local environment in India and work to address healthcare challenges in the country. We then aim to use the knowledge and successful practices gained in India as a model for broader expansion across the Global South.

Guided by our vision, ‘Leveraging technology to help deliver better treatments to patients as quickly as possible,’ we will continue working to improve access to healthcare around the world.

About Agatha Inc.

Agatha Inc. provides Agatha, a cloud-based platform for sharing, managing, and storing clinical trial- and quality-related documents, to medical institutions, pharmaceutical companies, medical device companies, contract research organizations (CROs), site management organizations (SMOs), clinical laboratories, and other organizations.

The company was founded with the vision of improving the quality, speed, and efficiency of clinical trials, clinical research, and manufacturing operations.

By leveraging the latest technologies, Agatha aims to build the systems and infrastructure that enable the development of new treatments and medicines, contribute to healthier lives for people around the world, and help create a future in which children everywhere have access to better living conditions, culture, technology, and healthcare.

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/