CLINICAL TRIALS MONITORING SERVICE

临床试验监测服务

• 批准号: 10250633
• 负责人: BARRY ANDERSON
• 金额: $ 87.11万
• 依托单位: THERADEX SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-05-01 至 2020-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10250633
• 关键词: Biological Assay; Biological Markers; Biological Products; Cancer Therapy Evaluation Program; Clinical Trials; Complex; Contractor; Contracts; Data; Dependence; Ensure; Infrastructure; Investigation; Laboratories; Monitor; Monitoring Clinical Trials; Process; Protocols documentation; Services; Site; Source; Systems Integration; Work; data management; good laboratory practice; manufacturing facility; quality assurance; success

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

本合同的范围是为NCI申办的临床试验提供数据管理、质量保证、临床试验监测和稽查能力，这些试验在美国境内和境外的参与研究中心进行，并监测生物制药生产设施的现行药品生产质量管理规范（cGMP）和进行研究性综合和综合生物标志物测定的核心实验室的药物非临床研究质量管理规范。承包商应建立、维护和加强运营基础设施，以支持工作说明书（SOW）中列出的任务。本工作说明书中的要求高度集成且复杂。工作说明书中描述的多个依赖关系需要紧密的流程/系统集成，以确保项目成功。为了协助CTEP履行其作为IND申办者的监管职责，并确保符合方案和监管要求以及源数据验证，临床试验监查服务