JMDC : Notice of Our New Initiative in the Field of Clinical Trials

Note: This document has been translated from the Japanese original for reference purposes only. In the event of any discrepancy between this translation and the Japanese original, the original shall prevail.

July 1, 2022

JMDC Inc.

Notice of Our New Initiative in the Field of Clinical Trials

JMDC Inc. (headquartered in Minato-ku, Tokyo; Yosuke Matsushima, President and CEO; the "Company") announces the commencement of a full-fledged initiative for the provision of its services in the field of clinical trials as described below:

1. Background

The Company, under its corporate philosophy of "Providing a Healthy and Rich Life for All Individuals," aims to realize a sustainable healthcare system through our efforts to resolve current issues in the medical field, such as "increasing medical expenses" and "regional disparities in medical services," by leveraging the power of data and ICT. More specifically, we are providing support in various forms to optimize healthcare services to all patients by building up data generated from various healthcare players and returning them to society at large.

As part of these efforts, we offer data utilization services to pharmaceutical companies in various fields, such as patient flow analysis and targeting selection in the marketing field and analysis support in the medical field. In addition, we are paying particular attention to the field of clinical trials based on the expectation that they will be more efficient going forward as a result of digitalization based on data utilization. The use of new clinical trial systems called electronic Patient Reported Outcome (ePRO) and Decentralized Clinical Trial (DCT), which utilizes home- visit nursing services, is already accelerating outside Japan. Also in Japan, digitalization is expected to reduce the burden on doctors and study participants and to improve the feasibility of clinical trials for rare diseases for which it is difficult to secure study participants. In addition, there are ongoing initiatives for the use of electronic medical records to prepare for case reports and the use of medical care data in participant recruitment, and there are significant expectations for initiatives to improve the efficiency of clinical trials by using Real World Data (RWD).

In response to these trends, the Company plans to work to establish a new model for clinical trials in Japan by utilizing healthcare big data to promote improved efficiency in clinical trials.

2. The Company's initiative

The Company is working to improve the efficiency of clinical trials by utilizing its healthcare big data to optimize clinical trial protocols and improve the efficiency of facility selection. In addition, ClinCloud Ltd. ("ClinCloud"), an Electronic Data Capture (EDC) service provider, joined the JMDC Group (the "Group") in 2021. Furthermore, Imepro, Inc. ("Imepro"), a company with full-support functions as a Contract Research Organization (CRO), has recently joined the Group. By joining forces with these companies, we will be able not only to provide various services in the field of clinical trials, but also to provide full-support functions as well as to conduct on a trial basis or propose the combination of digital and real capabilities in clinical trials.

ClinCloud is providing the Datatrak Enterprise Cloud service, an EDC service for clinical trials, under a business partnership with Datatrak, a major EDC vendor in the U.S. Datatrak Enterprise

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Note: This document has been translated from the Japanese original for reference purposes only. In the event of any discrepancy between this translation and the Japanese original, the original shall prevail.

Cloud is a highly reliable EDC service that has been adopted for over 4,000 clinical trials in 83 countries worldwide. ClinCloud is the top vendor for this service in Japan with a strong record of deployment to a wide range of customers in academia as well as the pharmaceutical industry. ClinCloud has also developed its proprietary EDC service called JPMS, which is specifically targeted at Post Marketing Surveillance (PMS). The actual operation of JPMS has started for several PMS projects at major pharmaceutical companies since last year.

Imepro has full-support functions as a CRO to support the entire process from the conception of a clinical research project to strategy formulation and practical use in the fields of both academic clinical research and clinical research conducted by pharmaceutical companies, with particular strengths in the areas of pediatric medicine and certain intractable diseases specified by the Ministry of Health, Labour and Welfare. Imepro has successfully won contracts for projects in a variety of areas beyond such specific areas as its recognition among clients improves due to the strong track record it has built up so far.

We will work to establish a new hybrid Clinical Trial (CT) model by combining existing clinical trial business with data and ICT-related knowhow, including ClinCloud's EDC business and Imepro's real operations of clinical trials as well as the Company's ePRO using RWD and Pep Up and participant recruitment through Melp AI-assisted symptoms consultation. We also plan to continue to focus on the expansion of data assets, mainly focusing on electronic medical records, which are expected to be utilized in clinical trials in the future (Figure 1).

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Note: This document has been translated from the Japanese original for reference purposes only. In the event of any discrepancy between this translation and the Japanese original, the original shall prevail.

■Related link: Imepro website https://imepro.jp/

[Summary profile of JMDC Inc.]

JMDC Inc. was established in 2002 as a pioneer in the healthcare big data industry. With its proprietary technology for anonymization, data analysis and aggregation, JMDC provides information services, such as health business support to payers, pharmaceutical product safety assessments, and health economic analysis, based on the analysis of more than 810 million items of payer claim data and more than 37 million items of health checkup data (as of March 2022). JMDC also works to realize a healthy society with its healthcare data and analytic capabilities through, for example, the provision of a web service (Pep Up) aimed at the provision of a single health indicator (i.e., what we call "health age") and health promotion.

URL:https://www.jmdc.co.jp/

[Inquiries about this release]

Public Relations Desk, Administration Department, JMDC Inc.

Email: jmdc-pr@jmdc.co.jp

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