According to an award notice posted Tuesday on SAM.gov, TRI will perform work in Bethesda, Maryland for the duration of the cost-plus-fixed fee contract, which includes a one-year base period and nine option years.
The contractor will help CCR comply with Food and Drug Administration and other U.S. and international regulations. In addition, both CCR-sponsored multi-center trials and non-CCR sites will be provided with management support as part of the total small business set-aside contract.
Other covered services are regulatory documentation; safety monitoring; clinical site assessment; sponsor quality management, administrative and trial master file support; medical writing as well as oversight and reporting.
NIH posted a request for proposals for the contract in September and made two solicitation amendments in October and November 2020.
TRI provides private industry, government agencies and other customers with services in the areas of communications, health and information technology. Its clinical research services include biopharmaceutical development support, health information services and health and environmental assessment.
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