CRO

合同研究组织（Contract Research Organization，CRO）是一种学术性或商业性的科学机构。申办者可委托其执行临床试验中的某些工作和任务。 CRO 可以作为制药企业的一种可借用的外部资源，可在短时间内迅速组织起一个具有高度专业化的和具有丰富临床研究经验的临床研究队伍，并能降低整个制药企业的管理费用。 Contract Research Organization, also called a Clinical Research Organization, (CRO) is a service organization that provides support to the pharmaceutical/biotech industry. CROs offer clients a wide range of "outsourced" pharmaceutical research services to aid in the drug and medical device research & development process. In the Code of Federal Regulations (CFR), the U.S. Food and Drug Administration regulations state that a CRO is "a person [i.e., a legal person, which may be a corporation] that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration." [21 CFR 312.3(b)] Services offered by CROs include: product development, formulation and manufacturing; clinical trial management (preclinical through phase IV); clinical, medical and safety monitoring; preclinical, toxicology, and clinical laboratory services for processing trial samples; data management, biostatistics and medical writing services for preparation of an FDA New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA); regulatory affairs support; and many other complementary services. CROs range from large, international full service organizations to small, niche specialty groups and can offer their clients the experience of moving a new drug or device from its conception to FDA marketing approval without the drug sponsor having to maintain a staff for these services. 公卫考场

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