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的AIDS（DAIDS）要求临床研究产品管理中心（CRPMC）的管理和运营，以在国内和国际上支持NIAID赞助的临床研究试验，并以HIV/AIDS及其合并症为核心。该合同将通过提供符合CGMP的设施，收据，存储，标签，包装，重新包装，运输，收购和处理研究产品来提供药品服务和研究产品管理。该合同将提供认知药物服务，包括评估协议草案；审查现场药房监控报告并维护现场审计药房报告数据库；为临床现场药剂师提供研究产品存储和稳定信息，研究药房实践指导以及研究产品管理活动；并对制造设施进行当前良好的制造实践（CGMP）审核。