NOI - External Institutional Review Board (IRB) Services for Multi-Site Studies

The National Heart, Lung, and Blood Institute (NHLBI) intends to award a sole source contract to Advarra, Inc. for continued Institutional Review Board (IRB) services supporting ongoing multi-site clinical research studies conducted under Investigational Device Exemption (IDE) and Investigational New Drug (IND) protocols. These services are required to ensure compliance with federal human subjects protection regulations and to maintain continuity of IRB oversight for active studies currently under review. This notice is not a request for competitive proposals; however, interested parties may submit a capability statement demonstrating their ability to meet the Government’s requirement.