Approaches to Improve the Core Competitive Power of Drug Clinical Trial Institutions / 中国药房

ABSTRACT

OBJECTIVE:To provide references for improving the quality of clinical trial of new drug (phase I-IV),guaranteeing participants' interests and enhancing the core competitive power of drug clinical trial institutions. METHODS: The advantages of both the guiding principle of Good Clinical Practice(GCP) and the quality standards of ISO/IEC170252005 were applied throughout the quality control process of clinical drug trial. RESULTS & CONCLUSIONS: To establish quality management and supervision system in China that is in line with the international norm and national condition by combining GCP principle with the quality standards of ISO/IEC17025 is conducive to the improvement of the quality of clinical drug trial and enhancement of the core competitive power of drug clinical trial institutions in China.