Naoki Tomotsugu
Keio Center for Clinical Research, Keio University School of Medicine Tokyo, Japan

Abstract:

[Objective/ Background]
Keio Center for Clinical Research (CCR) is one of the first academic research organizations in Japan, whose core mission is to facilitate high quality clinical research meeting global standard. Many challenges and issues have been so far identified and overcome so that CCR can provide comprehensive support to investigators, research subjects, and research sponsors worldwide.

[Results]
Our services, including data management, project management, biostatistics, clinical research coordination and administrative assistance, are at the moment provided for ca 30 investigator-initiated research in various therapeutic areas. Since 2008, we have assumed a function as Clinical Coordinating Center (CCC) for two sponsored global trials in an acute and severe disease, where patients’ eligibility has been centrally controlled for 24 hours daily. One of the studies involved 320 sites worldwide, out of which 51 sites in Japan were supervised by Keio CCC in collaboration with other CCCs in US and Europe. Despite its relatively limited enrollment efficiency, Japan excelled in rigorousness and precision of central screening and other research operations, thus achieved high data quality.

[Conclusions]
Keio CCR has successfully provided high quality research services for global trials, and will expand its activities as clinical research increases its complexity.