SAM #75N98026Q00234

Sole Source IRB Services for Multi-Site Clinical Studies – NHLBI/NIH

The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), is planning a sole source contract with Advarra, Inc. for external Institutional Review Board (IRB) services to support multi-site, FDA-regulated clinical studies under IDE and IND protocols. - Government Buyer: - National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Division of Intramural Research (DIR) - OEMs and Vendors: - Advarra, Inc. (sole source vendor) - Services Requested: - External IRB services for multi-site clinical research studies - Includes initial and continuing review of study protocols - Review of investigators, informed consent forms (including site-specific language), recruitment materials, protocol amendments, reportable events, and site closeout activities - Administrative reviews, emergency use reviews, and maintaining continuity of IRB oversight - Unique or Notable Requirements: - Must serve as IRB of record for ongoing multi-site FDA-regulated clinical studies (IDE/IND) - Services are required to ensure compliance with federal human subjects protection regulations and maintain subject safety and data integrity - Continuity of IRB oversight is critical for active studies - No specific products, part numbers, or quantities are listed - The notice is not a request for competitive proposals, but capability statements may be submitted by interested parties

Description

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.

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