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随着全球新药研发重心东移,我国医药市场和临床试验的市场迅速发展,药物临床试验机构建设任重而道远,引入以现场管理组织(SMO)管理模式为代表的国际通行管理模式,建立完善的质量管理体系,保持良好的运作机制,提高试验的综合管理水平,保证临床试验的质量,使国内药物临床试验机构完成的试验数据得到国际认可,将有利于推动中国药物临床试验与国际接轨的进程。
As the center of gravity of new drug research and development in the world moves eastward, the market for the pharmaceutical market and clinical trials in our country has been developing rapidly. The construction of drug clinical trial agencies has a long way to go and the introduction of an international management model represented by the management mode of on-site management organizations (SMO) Improve the quality management system, maintain a good operating mechanism, improve the comprehensive management of the trial, to ensure the quality of clinical trials, the experimental data of the domestic drug clinical trial agencies have been internationally recognized, will be conducive to promoting China’s drug clinical trials and international standards The process.