Resolution of issues in clinical trials that sponsors entrusted to contract research organizations in and outside Japan

Abstract

The difficulties Japanese sponsors experienced with Contract Research Organizations (CROs) (including Site Management Organizations (SMOs)) inside and outside Japan were analyzed to explore preventive measures from the viewpoint of the Japanese sponsor's quality assurance. The results of the analysis were grouped into four major service categories: monitoring, data management (DM), clinical laboratories and phase I sites. Characteristic issues were found in each category and there was also an indication of difficulties related to the difference in the interpretation of International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines between Japan and other countries. The corrective and preventive measures formulated in response to these issues were also discussed. Copyright © 2004 John Wiley & Sons, Ltd.