Clinical Research Products Management Center (CRPMC)
Clinical Research Products Management Center (CRPMC)
批准号:
10839747
负责人:
CARINA REMGSAMAI-NHE
金额:
$980.54万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2020
资助国家:
美国
项目状态:
已结题
起止时间:
2020-06-16 至 2024-06-15
关键词:
Acquired Immunodeficiency SyndromeAfricaAsiaCaribbean regionClinical ResearchCognitiveContractsCountryDatabasesEquipment and supply inventoriesEuropeGood Manufacturing ProcessHIV/AIDSInternationalLabelMonitorNational Institute of Allergy and Infectious DiseasePharmaceutical ServicesPharmacistsPharmacy facilityProcessProtocols documentationQualifyingRegulationReportingResearchShippingSiteSouth AmericaTechnical ExpertiseUnited StatesValidationWorkclinical research sitecomorbiditydesignexpirationmanufacturing facilityoperation
中文摘要
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英文摘要
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.
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Clinical Research Products Management Center (CRPMC)
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批准号:10551073
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项目类别:
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资助金额:$941.01万
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财政年份:2020
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负责人:CARINA REMGSAMAI-NHE
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依托单位:
Clinical Research Products Management Center (CRPMC)
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批准号:10329798
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项目类别:
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资助金额:$778.41万
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财政年份:2020
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负责人:CARINA REMGSAMAI-NHE
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依托单位:
COVID-19: Clinical Research Products Management Center (CRPMC)
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批准号:10329799
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项目类别:
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资助金额:$227.3万
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财政年份:2020
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负责人:CARINA REMGSAMAI-NHE
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依托单位:
COVID-19: Clinical Research Products Management Center (CRPMC)
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批准号:10551074
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项目类别:
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资助金额:$54.49万
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财政年份:2020
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负责人:CARINA REMGSAMAI-NHE
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依托单位:
海外基金