COVID-19: NIAID Regulatory Support Center

NIH Pandemic-Era Grants

Pandemic Era Grants

2023

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Principal Investigator: ASIMAH  RAFI
Organization: TECHNICAL RESOURCES INTERNATIONAL, INC.
Fiscal Year: 2023
Award: $5,439,404
Funding agency: National Institute of Allergy and Infectious Diseases

The purpose of this contract is to provide regulatory expertise and support to operate and manage the NIAID Regulatory Support Center (RSC) to provide a wide range of clinical research activities and programs for NIAID. The RSC provides comprehensive regulatory support to: 1) perform NIAID-funded and NIAID-sponsored domestic and international clinical trial research; 2) provide training in key functions of clinical trial research to NIAID staff, investigators, and collaborators; and 3) maintain all contract-associated data and records in the NIAID-Clinical Research Management System (N-CRMS), including the electronic submission of required regulatory information.  This project will provide regulatory support services for the COVID-19 clinical trial ACTIV-2 (Outpatient Monoclonal Antibodies And Other Therapies).

Terms: <2019 novel corona virus><2019 novel coronavirus><2019-nCoV><Agreement><COVID-19><COVID-19 virus><COVID19><COVID19 virus><CV-19><CV19><Clinical Research><Clinical Study><Clinical Treatment Moab><Clinical Trials><CoV-2><CoV2><Contracting Opportunities><Contracts><Data><Electronics><Funding><International><Investigational New Drug Application><Investigators><Monoclonal Antibodies><NIAID><National Institute of Allergy and Infectious Disease><Out-patients><Outpatients><Preparation><Protocol><Protocols documentation><Records><Research><Research Activity><Research Personnel><Researchers><Review Committee><SARS corona virus 2><SARS-CO-V2><SARS-COVID-2><SARS-CoV-2><SARS-CoV2><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Services><Severe Acute Respiratory Coronavirus 2><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome related corona virus 2><System><Training><Wuhan coronavirus><clinical applicability><clinical application><corona virus disease 2019><coronavirus disease 2019><coronavirus disease 2019 virus><coronavirus disease-19><coronavirus disease-19 virus><coronavirus infectious disease-19><electronic><electronic device><hCoV19><human subject protection><mAbs><meeting><meetings><monoclonal Abs><nCoV2><preparations><programs>