CSS and LDI Strengthen Collaboration to Support International Research Using Japanese Real-World Data
- 3 hours ago
- 4 min read
July 6th, 2026
CLINICAL STUDY SUPPORT, Inc.
Life Data Initiative
CLINICAL STUDY SUPPORT, Inc. (“CSS”; Head Office: Nagoya, Aichi; Chairman and President: Ken Takanashi) and Life Data Initiative (“LDI”; Headquarters: Kyoto, Kyoto; Representative Director: Tomohiro Kuroda) today announced that they will strengthen their collaboration to support international research using “Millennial Medical Record,”(1) a real-world database developed under Japan’s Next Generation Medical Infrastructure Act(2).
Through this collaboration, CSS and LDI will strengthen their framework for responding to inquiries and supporting projects from overseas pharmaceutical companies and other organizations seeking to use Japanese real-world data to inform research and development strategies involving the Japanese market. The initiative aims to facilitate international research and development using real-world data from Japan.
Background
Real-world data is increasingly important for decision-making and evidence generation in pharmaceutical research and development. Japanese healthcare data is also gaining attention in global development strategies, including those involving Asia, as overseas pharmaceutical companies consider activities related to the Japanese market.
LDI is certified under Japan’s Next Generation Medical Infrastructure Act as a Certified Anonymously and Pseudonymously Processed Medical Information Creator. Together with NTT DATA, a certified contractor for handling medical and related information, LDI operates Millennial Medical Record, a certified database under the Act. Medical information accumulated in the database is processed into anonymized data and provided to pharmaceutical companies, academic institutions, and other data users.
The database supports research using structured data, such as claims data, as well as unstructured data in electronic medical records, including clinical notes, progress records, and clinical summaries. This enables the conduct of database research that more closely reflects clinical practice.
Using such data in international research requires compliance with the Act, disease-area knowledge, expertise in electronic medical record data, and support from planning through analysis and reporting. Through this initiative, CSS and LDI will establish a framework that enables overseas pharmaceutical companies and other organizations to confidently conduct research using Japanese real-world data.
Overview of the Initiative
Starting in July 2026, CSS and LDI will support research activities under the following roles.
CSS
CSS will work with LDI and NTT DATA to support overseas pharmaceutical companies and other organizations considering the use of Millennial Medical Record. CSS will support research consultations, concept development, analysis planning, data analysis, reporting, and manuscript development. Drawing on its extensive experience in clinical research, epidemiological studies, and real-world data research in Japan and internationally, CSS will support the development of research plans tailored to the specific needs of each client.
LDI and NTT DATA
LDI and NTT DATA will provide anonymized medical data under the Act to CSS. Both organizations will also share knowledge with CSS on the Millennial Medical Record data structure, compliance requirements, and analysis of unstructured data, supporting database research for international research and development needs.
By combining CSS’s understanding of global user needs with LDI’s and NTT DATA’s expertise in unstructured data analysis, the collaboration will help overseas pharmaceutical companies evaluate research opportunities using Japanese real-world data more smoothly.
Looking Ahead
Through this initiative, CSS and LDI will expand opportunities for overseas pharmaceutical companies to use Japanese real-world data and promote its appropriate use in global research and post-marketing strategies.
The collaboration is expected to support international development strategies involving the Japanese market and demonstrate the international value of Japanese real-world data.
Going forward, CSS and LDI will respond to overseas research inquiries and data needs while continuing to strengthen support for international research and development, contributing to medical research and innovation in Japan.
Notes
Millennial Medical Record:
Millennial Medical Record is an initiative under the Next Generation Medical Infrastructure Act that processes medical information from medical institutions and other sources into statistical, anonymized, or pseudonymized data, provides it to data users, and uses it for advanced research and development in healthcare and medicine as well as the creation of new industries.
Next Generation Medical Infrastructure Act:
The formal name of the Act is the Act on Anonymized Medical Data and Pseudonymized Medical Data Contributing to Research and Development in the Medical Field. The Act provides a legal framework for processing personal medical information so that individuals cannot be identified and this information may be used in the research and development of new drugs, treatment methods, and other medical innovations.
About CLINICAL STUDY SUPPORT, Inc.
CSS has extensive experience supporting clinical research in Japan and overseas, including clinical trials, epidemiological studies, and survey research. Its services cover research planning, study operations, data management, statistical analysis, reporting, and manuscript development.
CSS has also established a collaborative framework with Evidera, Inc. in real-world research in Japan, and draws on its experience of supporting research for global pharmaceutical companies.
About Life Data Initiative
LDI is certified by the Japanese government as a provider under the Next Generation Medical Infrastructure Act. In collaboration with medical institutions across Japan, LDI develops and operates a platform for providing medical data and has extensive experience using data under the Act.
By collecting health and medical data and providing services to both data users and participating institutions, LDI promotes the effective use of medical information and seeks to advance healthcare, pharmaceutical development, and research through the application of innovative technologies. Therefore, demonstrating the international value of Japanese real-world data.
Contact
CLINICAL STUDY SUPPORT, Inc.
Life Data Initiative