NIH RFI: National Heart, Lung, and Blood Institute (NHLBI) Clinical Research Operations and Management (CROMS)

Notice ID: 75N92025R0314

The National Heart, Lung, and Blood Institute (NHLBI) is seeking information on operations and management support services for clinical research studies supported by the National Institute of Dental and Craniofacial Research (NIDCR). The information obtained will be used for planning purposes for a requirement to provide NIDCR extramural and intramural staff with tools essential for the effective administration, oversight and coordination of NIDCR’s clinical studies. It will provide adjunct expertise, administrative support, and other tools and resources to assure efficient and high-quality conduct of NIDCR’s clinical research program. Specific emphasis includes clinical site monitoring, coordination and logistical support for data and safety monitoring committee meetings, technical expertise to assess clinical study documentation, coordination of quality management and other oversight report reviews, safety event processing and dissemination for NIDCR review, and Investigational New Drug (IND) and Investigational Device Exemption (IDE) submissions to the Food and Drug Administration (FDA). In addition, the requirement will provide support for maintaining and enhancing the NIDCR internal information management systems used to manage and coordinate oversight activities for NIDCR’s clinical research program.

NHLBI is requesting public comment to guide efforts to enhance the prospective acquisition requirement for NIDCR’s Clinical Research Operations and Management Support (CROMS) contract to promote open competition and facilitate the receipt of responses by qualified vendors. The purpose of this RFI is to identify business concerns from vendors interested in and capable of performing the work described herein, as well as to solicit information pertaining to the capabilities of such qualified vendors to perform the specified services. The goal is to gather feedback from qualified vendors to improve the requirement and determine if limitations exist with the submission proposals.

The Government plans to issue a solicitation on or about December 2024.

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