| 在我国药物临床试验机构建设中引入国际通行管理模式 |
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| 引用本文： | 王天勋,茅益民,宫岩华,梁文娟.在我国药物临床试验机构建设中引入国际通行管理模式[J].中国新药杂志,2012(7):728-731. |
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| 作者姓名： | 王天勋 茅益民 宫岩华 梁文娟 |
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| 作者单位： | 润东医药研发(上海)有限公司;上海交通大学医学院附属仁济医院;全国医药技术市场协会CRO联合体 |
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| 基金项目： | 国家重大新药创制科技重大专项:创新药物研究开发技术平台建设——抗慢性乙型病毒性肝炎新药临床评价研究平台的构筑(2008ZX09312-007) |
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| 摘 要： | 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。
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| 关 键 词： | 药物临床试验机构 SMO管理模式 临床研究协调员(CRC) |
Introducing internationally recognized management method in Chinese clinical trial institution |
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| WANG Tian-xun,MAO Yi-min,GONG Yan-hua,LIANG Wen-juan.Introducing internationally recognized management method in Chinese clinical trial institution[J].Chinese Journal of New Drugs,2012(7):728-731. |
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| Authors: | WANG Tian-xun MAO Yi-min GONG Yan-hua LIANG Wen-juan |
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| Institution: | 1(1 Rundo International Pharmaceutical Research & Development Co.,Ltd.,Shanghai 200001,China; 2 Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai 200001,China; 3 Contract Research Organization Union,China National Association of Pharmaceutical and Medical Equipment Industry Technical Market,Beijing 100044,China) |
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| Abstract: | With the movement of global drug research and development centers to the East,Chinese medicine and clinical trial markets have developed rapidly.Clinical trial institutions,however,still have got a long way to go.Only by introducing Site Management Organizations(SMO,currently the most internationally recognized management method),establishing a strong quality management system,maintaining good operation procedures,improving clinical trial management and assuring trial quality will China’s clinical trials can meet international standards. |
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| Keywords: | clinical trial institution SMO management mode clinical research coordinator(CRC) |
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