CLINICAL TRIALS MONITORING SERVICE

该合同的范围是提供数据管理、质量保证、临床试验监测和审计能力，为NCI在美国境内外的参与地点赞助的临床试验提供数据管理、质量保证、临床试验监测和审计能力，并监测生物制药生产设施的现行良好生产规范（cGMP）和核心实验室的良好实验室规范，进行研究性整体和综合生物标志物分析。承包商应建造、维护和增强运营基础设施，以支持工作说明书（SOW）中列出的任务。此SOW中的需求是高度集成且复杂的。SOW中描述的多个依赖关系需要紧密的过程/系统集成，以确保项目成功。协助CTEP履行其作为IND发起人的监管责任，并确保符合方案和监管要求以及源数据验证，临床试验监测服务

The scope of this contract is to provide data management, quality assurance, clinical trial monitoring and auditing capability, for NCI sponsored clinical trials at participating sites both within and outside of the U.S and monitoring for current Good Manufacturing Practices (cGMP) for biopharmaceutical manufacturing facilities and Good Laboratory Practices for Core Laboratories performing investigational integral and integrated biomarker assays. The Contractor shall build, maintain, and enhance the operational infrastructure to support the tasks listed within the Statement of Work (SOW). The requirements in this SOW are highly integrated and complex. The multiple dependencies described within the SOW require tight process/system integration to ensure project success. To assist the CTEP in fulfilling its regulatory responsibilities as an IND sponsor and to assure compliance with protocol and regulatory requirements and source data verification, the Clinical Trials Monitoring Service