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需要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。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。 该项目将支持研究产品管理和研究产品的COVID-19临床试验A5401（Activ-2门诊单克隆抗体和其他疗法）。