COVID-19: Clinical Research Products Development Center (CRPMC)

COVID-19：临床研究产品开发中心 (CRPMC)

• 批准号: 10244841
• 负责人: NEERAJA PUTTA
• 金额: $ 119.67万
• 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/10244841
• 关键词: AIDS clinical trial group; COVID-19; Clinical Research; Clinical Trials; Cognitive; Contracts; Databases; International; Label; Monitor; Monoclonal Antibodies; National Institute of Allergy and Infectious Disease; Outpatients; Pharmaceutical Services; Pharmacists; Pharmacy facility; Protocols documentation; Reporting; Research; Shipping; Site; clinical research site; manufacturing facility; operation; product development

NIAID 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. 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. This project will support study product management and distribution of the study products for COVID-19 clinical trial A5401 (ACTIV-2 Outpatient Monoclonal Antibodies And Other Therapies).

NIAID要求管理和运营临床研究产品管理中心（CRPMC），以支持NIAID申办的国内和国际临床研究试验。本合同将通过提供符合cGMP的设施、研究产品的接收、储存、贴标、包装、重新包装、运输、获取和处置来提供药学服务和研究产品管理。该合同将提供认知药学服务，包括评价方案草案;审查研究中心药房监查报告并维护研究中心稽查药房报告数据库;向临床研究中心药剂师提供研究药物储存和稳定性信息、研究药房实践指南和研究药物管理活动;以及对生产设施进行现行药品生产质量管理规范（cGMP）稽查。 本项目将支持COVID-19临床试验A5401（ACTIV-2门诊单克隆抗体和其他治疗）的研究产品管理和研究产品分销。