title: [Basic considerations during outsourcing of clinical data management services].
abstract: With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.
authors.forename: Tong
authors.initials: T
authors.lastname: Shen
authors.forename: Yan
authors.initials: Y
authors.lastname: Liu
mesh_terms: D002986:Clinical Trials as Topic; D003625:Data Collection / Q000379:methods*; D016247:Information Storage and Retrieval / Q000379:methods*; D020416:Outsourced Services; D011786:Quality Control