Clinical Research Products Development Center (CRPMC)

临床研究产品开发中心（CRPMC）

• 批准号: 10197287
• 负责人: NEERAJA PUTTA
• 金额: $ 757.16万
• 依托单位: FISHER BIOSERVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-16 至 2021-06-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10197287
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Africa; Asia; Caribbean region; Clinical Research; Cognitive; Contracts; Country; Databases; Equipment and supply inventories; Europe; International; Label; Monitor; National Institute of Allergy and Infectious Disease; Pharmaceutical Services; Pharmacists; Pharmacy facility; Process; Protocols documentation; Regulation; Reporting; Research; Shipping; Ships; Site; South America; Technical Expertise; United States; Validation; Work; clinical research site; comorbidity; design; expiration; manufacturing facility; operation; product development

NIAID Division of AIDS (DAIDS) has a requirement for the management and operation of a Clinical Research Products Management Center (CRPMC) to support NIAID-sponsored clinical research trials both domestically and internationally, with a core focus of HIV/AIDS and its co-morbidities. This contract will provide pharmaceutical services and study product management by providing a cGMP-compliant facility, receipt, storage, labeling, packaging, repackaging, shipping, acquiring, and disposition of study products. This contract will provide cognitive pharmaceutical services including evaluating draft protocols; reviewing site pharmacy monitoring reports and maintaining a site audit pharmacy report database; providing study product storage and stability information, guidance in research pharmacy practice and study product management activities to clinical site pharmacists; and conducting Current Good Manufacturing Practice (cGMP) audits of manufacturing facilities.

NIAID艾滋病司(DAIDS)要求管理和运营一个临床研究产品管理中心(CRPMC)，以支持NIAID赞助的国内和国际临床研究试验，其核心重点是艾滋病毒/艾滋病及其合并症。该合同将通过提供符合cGMP的设施、接收、储存、标签、包装、重新包装、运输、获取和处置研究产品来提供药物服务和研究产品管理。该合同将提供认知制药服务，包括评估协议草案；审查现场药房监测报告并维护现场审计药房报告数据库；向临床现场药剂师提供研究产品储存和稳定性信息、研究药房实践和研究产品管理活动方面的指导；以及对生产设施进行当前的良好制造规范(CGMP)审计。