2nd DIA Clinical Operation & Monitoring Workshop in Japan

In keen global competition of drug development, Japan has been required to lower the cost and increase the speed of clinical trials while maintaining the quality of clinical operations. Due to these circumstances various actions aimed at improvement of productivity are underway in sponsors and clinical trial sites. On the other hand, unnecessary data collection and procedures are often seen and these inhibit the productivity in the sites. At last year’s meeting the “Lean Six Sigma” procedure was introduced and discussed to resolve CRF related issues and to lead to improvement activities of clinical trials. During this session we will go one step further from the topics of last year and introduce the efforts to promote patients’ enrolment in a site, the activities to improve productivity, and efforts to reduce queries of CRF in a pharmaceutical company. Concrete efforts using the procedure of Lean Six Sigma in collaboration with a sponsor and a clinical trial site will be also introduced. In addition, Toshio Miyata, who previously worked on revising GCP ministerial ordinance/notification at the Ministry of Health, Labour and Welfare, Pharmaceutical and Food Safety Bureau Evaluation and Licensing Division, will point out current wasteful processes in clinical trials.