ITOCHU Corporation (headquartered in Minato-ku, Tokyo; Masahiro Okafuji, President & CEO; hereinafter “ITOCHU”) announced today that A2 Healthcare Corp. (headquartered in Bunkyo-ku, Tokyo; Tadashi Katori, President & CEO; hereinafter “A2 Healthcare”), a subsidiary of ITOCHU, and Medidata Solutions, Inc. (headquartered in Chiyoda-ku, Tokyo; Takeru Yamamoto, Managing Director, Asia-Pacific Region; hereinafter “Medidata”) have agreed to further enhance their past cooperative relationship by introducing Risk-Based Monitoring (hereinafter “RBM”) that will ensure the reliability of clinical trials required for the development of drugs and medical equipment and will improve efficiency and reduce costs in the development of pharmaceutical products and medical equipment in a suitable form for the Japanese clinical trial environment.

Along with intensifying competition in the development of pharmaceutical products and medical equipment in recent years, a further improvement in the quality and speed of clinical trials is required. As one of the methods to realize this, regulatory authorities in Japan, the United States and Europe recommend the implementation of RBM. RBM is becoming prevalent in the United States under the leadership of TransCelerate BioPharma Inc. (hereinafter “TransCelerate”), an NPO jointly established by leading global pharmaceutical companies aiming for a further improvement in the efficiency of clinical trials. Expectations for RBM are also large in the Japanese pharmaceutical and medical equipment industries, and some of the leading pharmaceutical companies have already begun applying RBM. Many other pharmaceutical and medical equipment companies have also specifically begun considering the introduction of RBM.

Given these situations, A2 Healthcare, with strength in the application of IT for statistical analyses and clinical trials and Medidata, the leading global provider of cloud-based solutions for clinical research in life sciences including Electronic Data Capture (electronic collection of clinical data), and who also manages abundant clinical data, have agreed to jointly develop RBM solutions suitable for the clinical trial environment in Japan by mutually providing the expertise that they have, with the aim of commencing an RBM test by the end of the year.

- A2 Healthcare will accelerate the speed and promote the quality improvement of the development of pharmaceutical and medical equipment companies by applying RBM comprehensively through the provision of the following services.
・ Preparation of clinical trial protocol taking RBM into account by making full use of statistical analysis know-how
・ Formulation of an RBM implementation plan taking into consideration characteristics of investigational agents and protocol and the clinical trial environment in Japan
・ Early discovery of quality risks and a response to them through central monitoring that conducts systematic analysis
・ Construction and operation of Medidata TSDV (Targeted Source Document Verification: well-targeted inspection of source documents)

- Medidata will provide the following tools that support the introduction of RBM through the Medidata Clinical Cloud®, its own service platform.
・ Medidata TSDV
A tool to support the preparation and execution of a TSDV plan at the time of applying RBM
・ Medidata SQM (Site Quality Management)
A data analysis tool to support central monitoring, which is the key at the time of applying RBM from the standpoint of the work quality of medical facilities participating in clinical trials
・ CSA (Central Statistical Analytics)
A data analysis tool to support central monitoring that visualizes Patient Profile (test data for each trial subject), analyzes trends and automatically detects outliers

In addition, Medidata will also provide consulting services including the formulation of strategies and operating processes to introduce RBM, taking advantage of its global track record based on its close cooperation with TransCelerate.

Overview of Medidata

Medidata is a global company that will bring about a revolution in clinical development in the life science industry with its cloud-based leading-edge applications and advanced data analysis. By using the Medidata Clinical Cloud®, Medidata will be able to improve the productivity and quality of a broad range of clinical trials from planning to implementation, to management and reporting. Customers of Medidata include the names of more than 90% of the world’s top 25 pharmaceutical companies as well as innovative biotechnology companies, as well as companies providing medical diagnosis and equipment, core university hospitals and contract research organizations (CRO).

URL: https://www.mdsol.com/