March 11, 2024
EPNextS, Inc.

EPNextS, Inc. (Headquarters: Shinjuku-ku, Tokyo; Representative Director: Tatsuma Nagaoka; hereinafter “EPNextS”) will commence a collaboration with NTT DATA Corporation (Headquarters: Koto-ku, Tokyo; Representative Director, President and CEO: Yutaka Sasaki; hereinafter “NTT DATA”) starting in March 2024, with the aim of promoting the utilization of electronic medical record data for pharmaceutical companies and academia. NTT DATA has expertise in the first certified project under the Next Generation Medical Infrastructure Act*¹, known as “Millennium Medical Record^®,” *² and NDB, *³ which is the National Database of Health Insurance Claims and Specific Health Checkups of Japan. The company also possesses one of the largest medical big data analysis and utilization capabilities in Japan. Through this collaboration, it will be possible to combine EPNextS’s expertise and customer base in clinical trials, clinical research, database studies, and surveys with the electronic medical record data accumulated in Millennium Medical Record^®. This will enable comprehensive support for electronic medical record data users—from research planning and review to statistical analysis, and manuscript preparation and submission—thereby further promoting the utilization of electronic medical record data.
Moving forward, both companies will contribute to the further development of the medical field by conducting research that leverages the unique features of Millennium Medical Record^®, which can collect unstructured data, including patient background information and clinical outcomes such as treatment effects.

1. Background
EPS Corporation (Headquarters: Shinjuku-ku, Tokyo; Representative Director: Takehisa Yamada), a subsidiary of EPNextS, engages in the creation of clinical evidence using real-world data (Real-World Evidence: RWE), and proposes research designs, etc., leveraging its unique expertise and assets for academia and pharmaceutical companies. However, a challenge existed in accessing electronic medical record data that retains unstructured data, which is necessary to propose a broader range of research designs and higher levels of evidence.
Meanwhile, under the Next-Generation Medical Infrastructure Act, NTT DATA — certified as a Medical Information Handling Contractor under the Certified Producer of Anonymized Medical Data, Life Data Initiative (LDI) General Incorporated Association — has been anonymizing medical information, including electronic medical record data accumulated by the Millennium Medical Record^®, and providing it to users such as pharmaceutical companies and academia. Furthermore, Millennium Medical Record^® is unique in that it possesses unstructured data containing information related to clinical outcomes, such as special test values, progress notes, clinical summaries, and various reports, in addition to the conventional medical real-world data that handles only structured data.
EPNextS believes that by consolidating the knowledge of the EPNextS Group’s Real-World Data Scientists and over 1,000 CRAs4 and CRCs5 respectively, they can maximize the utilization of unstructured data from Millennium Medical Record^®. By leveraging this expertise, EPNextS aims to address challenges such as study planning, the application of know-how in statistical analysis and manuscript preparation, and the rapid proposal of solutions to data users. To achieve this, EPNextS has partnered with NTT DATA, a Medical Information Handling Contractor with extensive experience, as a certified collaborator.

2. About the Collaboration
EPNextS and NTT DATA will undertake the following initiatives starting in March 2024 with the aim of promoting the utilization of electronic medical record data:

• Joint proposals to data users, such as pharmaceutical companies and academia
• Creation of new use cases
• Implementation of a validation study*⁶ of outcome definitions

In particular, for validation studies of outcome definition, when relying only on health insurance claims data and DPC data*⁷, it is often said to be difficult to ensure the accuracy of outcome definitions. This is because key evaluation metrics derived from clinical test values and medical records cannot be obtained from structured data alone. By utilizing the Millennium Medical Record^® data, however, outcome definitions can be established not only from health insurance claims data and DPC data but also from evaluation metrics obtained from clinical test values and medical records held as electronic health record data. This will allow for outcome research with a higher level of evidence.

Additionally, as the revised Next Generation Medical Infrastructure Act is scheduled to be enforced in FY2024, both companies will also explore the utilization of the newly established pseudonymized medical information, etc.

3. Future Outlook
In addition to the services traditionally provided by EPNextS and EPS Corporation through collaboration with various database operators, the companies will now also conduct studies to create high-quality research and new use cases, leveraging the unique features of the Millennium Medical Record^® database which enables the utilization of unstructured data, including patient background information and treatment status, starting with validation studies. Through these initiatives, the companies will contribute to the further development of the medical field.

■About EPNextS
EPNextS, Inc. is a healthcare solution provider overseeing the core businesses (CRO*⁸, SMO*⁹, CSO*¹⁰) within the EPS Group, which is led by EPS Holdings, Inc., founded in 1991 as a pioneer in CRO. EPNextS is committed to creating innovative business solutions in the healthcare sector by consolidating the comprehensive strengths of the EPNextS Group.

■About NTT DATA
NTT DATA Corporation aims to create a prosperous and harmonious society by providing IT services in more than 50 countries worldwide.
To achieve business transformation and solve social issues utilizing digital technology, we look toward the future together with our clients, offering a variety of services ranging from consulting and system development to system operation.

*1 Next Generation Medical Infrastructure Act: This Act aims to promote advanced research and development and the creation of new industries related to health and medical care, thereby contributing to the creation of a healthy and long-lived society. This is achieved by regulating the handling of medical information and anonymized medical information, as well as providing certification for businesses that create anonymized medical information for the purpose of advancing research and development in the medical field. (Source (only available in Japanese): Cabinet Office, “About the Next Generation Medical Infrastructure Act” (https://www8.cao.go.jp/iryou/gaiyou/gaiyou.html))
*2 Millennium Medical Record: An initiative based on the “Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field” (Next Generation Medical Infrastructure Act) to utilize medical information, acquired from medical institutions, for advanced research and development and new industry creation related to health and medical care, by statistically processing or anonymizing the data and providing it to data users.
*3 NDB: National Data Base, an abbreviation for the National Database of Health Insurance Claims and Specific Health Checkups of Japan.
*4 CRA：Clinical Research Associate
*5 CRC：Clinical Research Coordinator
*6 Validation Study: An investigation conducted as part of the secondary use of data, where the validity of information contained in the data is checked against another highly reliable source of information. (Source: PMDA, “Guidelines for the Conduct of Pharmacoepidemiological Studies in Drug Safety Assessment with Medical Information Databases”)
*7 DPC (Diagnosis Procedure Combination) Data: A classification system for patient groups categorized by disease name and treatment details. DPC data refers to the data generated as a result of calculated remuneration in hospitals designated by the Ministry of Health, Labour and Welfare, based on Diagnosis Procedure Combination/Per-Diem Payment System (the DPC system).
*8 CRO：Contract Research Organization
*9 SMO：Site Management Organization
*10 CSO：Contract Sales Organization

*”Millennium Medical Record^®” is a registered trademark of the Life Data Initiative General Incorporated Association in Japan.
*Other product names, company names, and organization names are trademarks or registered trademarks of their respective companies.

[For inquiries regarding this news release]
EPNextS, Inc., Public Relations Department
Email:epn-cco@eps.co.jp