CLINICAL TRIALS MONITORING SERVICE_ Moonshot support

临床试验监测服务_Moonshot 支持

• 批准号: 10789829
• 负责人: BARRY ANDERSON
• 金额: $ 36万
• 依托单位: THERADEX SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10789829
• 关键词: Adherence; Biological Assay; Biological Products; Cancer Center; Clinical Trials; Clinical Trials Network; Collaborations; Community Clinical Oncology Program; Conduct Clinical Trials; Contract Services; Data; Division of Cancer Treatment and Diagnosis; Ensure; Funding; Funding Agency; Good Clinical Practice; Good Manufacturing Process; Guidelines; Institution; International; Investigational Therapies; Laboratories; Medidata; Monitor; Monitoring Clinical Trials; Patients; Phase; Phase II Clinical Trials; Policies; Procedures; Process; Protocols documentation; Quality Control; Randomized; Regulation; Research; Resources; Services; Site; Site Visit; Support Contracts; System; United States Dept. of Health and Human Services; United States Food and Drug Administration; Visit; data integrity; data management; early phase clinical trial; good laboratory practice; manufacturing facility; patient registry; quality assurance; research and development; symposium

This is a Research and Development Support contract. The purpose of this acquisition is to assist the NCI in fulfilling its responsibilities to the Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) regulations as IND sponsor and funding agency. The scope of the Clinical Trials Monitoring Service (CTMS) contract is to provide data management, quality assurance, clinical trial monitoring, and auditing capability for NCI sponsored clinical trials conducted by the NCI's Experimental Therapeutics Clinical Trials Network (ETCTN) at participating sites both domestically and internationally. Additionally, the CTMS contract provides a mechanism for the auditing of biopharmaceutical manufacturing facilities to ensure compliance with current Good Manufacturing Practices (GMP) and compliance with Good Laboratory Practices (GLP) for laboratories performing integral assays.

这是一份研发支持合同。此次收购的目的是协助NCI履行其作为IND发起人和资助机构对食品和药物管理局（FDA）和卫生与人类服务部（DHHS）法规的责任。临床试验监测服务（CTMS）合同的范围是为NCI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，这些临床试验由NCI的实验治疗临床试验网络（ETCTN）在国内和国际参与地点进行。此外，CTMS合同提供了一种审核生物制药生产设施的机制，以确保执行整体测定的实验室符合现行的良好生产规范（GMP）和良好实验室规范（GLP）。