COVID-19: NIAID Regulatory Support Center

Technical Resources International, Inc., Bethesda MD

Investigators

Abstract

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).