December 21, 2018
Site Support Institute Co., Ltd.

Started support services for specified clinical research Assuring the quality of research support through a unique certification system

Site Support Institute Co., Ltd. (Head Office: Minato-ku, Tokyo; President and CEO: Akihisa Mitake), a subsidiary company of CMIC Holdings Co., Ltd., that operates Site Management Organization business, hereby inform you that we have recently commenced a clinical research support service in accordance with the Clinical Trials Act.

The Clinical Trials Act was enacted in April 2018, and when medical institutions and research institutions conduct specified clinical research, they are required to manage conflicts of interest, preserve drug administration records, conduct monitoring and others.

The need for research support from doctors and researchers is increasing in the face of the need to respond to the new law. In response to this demand, we began providing support services such as monitoring and auditing of specified clinical researches based on our own certification system. By identifying the detailed needs of doctors and researchers, we aim to actively support projects that are difficult to be supported by Clinical Research Associates (CRAs). We expect to be able to provide a wide range of clinical research support services by leveraging our research support know-how.

In conjunction with the launch of the new services, we established the Clinical Trial Solutions Group on December 1, 2018. The Group will provide high-quality clinical research support services through the establishment of a clinical research monitoring education program and the operation of a renewal-based in-house certification system.

Accredited personnel are already active at sites around the country, and a system is now in place to respond to clinical research on a variety of scales. Taking advantage of the strengths we have built up as a leading SMO company, we will respond swiftly to the new needs of academia. In addition, we will make effective use of the resources of the CMIC Group to support all clinical research.

Site Support Institute Co., Ltd.

SSI (Site Support Institute) is a leading company of the SMO (Site Management Organization) and is a nationwide company that undertakes and acts on behalf of medical institutions for clinical trial-related work. We provide total support for all aspects of clinical trial implementation from implementation to management.
We are also leveraging our strengths in business collaboration with medical institutions to develop new businesses in the healthcare field. For details, please refer to the website. https://www.j-smo.com/

Inquiries

Site Support Institute Business Planning Office
Tel: 03-6779-8160 / E-mail: ssi-cs_webform@j-smo.com

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