SMO or Site Management Organization is originated from clinical fields in the United States. The number of SMO in Japan has been vigorously increasing, and it is estimated over 100 companies are now running as an "SMO" in Japan.
Site Support Institute Co., Ltd. (SSI) is one of the leading nation-wide SMOs in Japan with 516 contracted medical sites as of March 31, 2006.
Since the purpose of clinical trials is to investigate the biological response of human subjects, we are required to comply with strict regulations and guidelines set by laws, exemplifying GCP (Good Clinical Practice) of MHLW (Japanese Ministry of Health, Labor and Welfare). With complying with GCP, every clinical trial must secure the subjects' human rights and safety as well as guaranteed ethical and scientific justification.
SSI manages various duties derived from clinical trial implementation. We particularly assist medical institutions with performing various tasks throughout clinical trial processes. SSI staff has an expertise in clinical trials so that clinical trial participants can fully rely upon them.
SMA (Site Management Associate) and CRC (Clinical Research Coordinator)
How SSI assists clinical trials?
Two types of specific experts, named "Site Management Associate (SMA)" and the "Clinical Research Coordinator (CRC)" drive SSI's support workforce.
Site Management Associate (SMA)
SMAs (Site Management Associates) play the role of effective liaison with pharmaceutical manufacturers (sponsors of clinical trials) at medical institutions. The expert staff assists in clinical trials from the aspects of administrative tasks and clinical trial project management.
SMAs have a thorough mastery of the GCP (Good Clinical Practice), which we must follow for valid clinical data. SMAs also provide medical clinical trial institutions with adequate assist and support.
Support from SMAs
As clinical trials are to investigate the biological response of human subjects, GCP states strict guidelines on performing duties related to document preparation and storage, as well as other administrative procedures and work practices.
SMAs assist with administrative responsibilities such as duties related to various contracts, filing of documents and records as well as responding to inquiries. They help ensure that the clinical trials meet the standards set by GCP while maintaining a seamless operation. As a consequence, they assist in improving the quality of the trials.
Clinical Research Coordinator (CRC)
Clinical Research Coordinators (CRCs) help doctors improve the quality of clinical trial implementation and minimize their workload increase.
CRCs of SSI are all certified as medical professionals (i.e. nurses or clinical technologists) to perform appropriate support under supervision of clinical Investigators.
Support from CRCs
CRCs act like doctors' partners rather than assistants, and proactively give support throughout the process. This includes selecting patients for clinical trial subjects, giving presentations on the procedure to patients, planning and managing the schedule for examinations and the administration of drugs, and collecting and managing various materials and data.
Despite importance, clinical trial implementation can be time-consuming and a considerable burden for doctors and staff in medical sites. CRCs help ensure that the clinical trials are performed seamlessly and minimize the stress placed on both the doctors and the patients.
| Who is SMO? |
| What is GCP? |
| How medeicine is manufactured |
Nishi-Gotanda, Shinagawa-ku, Tokyo 141-0031 JAPAN.
Tel：+81-3-5436-2820
Fax：+81-3-5436-2822
