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随着国际、国内药物临床试验相关法规的日趋完善,药物临床试验的质量也越来越受到广泛关注,为了既能实施更高质量的临床试验又能有效配置和利用资源,很多制药企业采用外包形式的临床试验管理。临床试验的数据管理作为药物临床试验的一个重要组成部分,也可以采取外包的形式,其实施的基础是选择优质的合同研究组织、采取适宜的外包形式、并能进行有效的质量控制以确保临床试验数据的真实性、完整性和准确性。
With the international and domestic laws and regulations on drug clinical trials are perfecting, the quality of drug clinical trials is also receiving more and more attention. In order to be able to implement higher quality clinical trials and effectively allocate and utilize resources, many pharmaceutical companies use outsourcing Form of clinical trial management. Data management of clinical trials as an important part of clinical trials of drugs can also take the form of outsourcing, which is based on the selection of high-quality contract research organizations, appropriate outsourcing and effective quality control to ensure clinical The authenticity, completeness and accuracy of the test data.