SAM #75N98027R00015

NIBIB Clinical Validation Core Capability Request

The National Institute of Biomedical Imaging and Bioengineering (NIBIB), within the National Institutes of Health (NIH), is seeking capability information for a Clinical Validation Core supporting diagnostic and monitoring technologies. - Government buyer: NIH, specifically NIBIB; no office-level buyer is identified. - Requested service: Clinical validation core services for analytical and clinical validation of diagnostic devices. - Develop standard validation protocols and templated reports, and provide technical and clinical expertise. - Provide laboratory equipment and BioSafety Level 2 (BSL-2) or higher facilities, plus clinical sites and resources for sample collection and storage. - Support usability and human-factors testing, data management and reporting, and legal work related to nondisclosure agreements (NDAs) and material transfer agreements (MTAs). - Capacity and expertise: Respondents should demonstrate the ability to support at least 50 validation studies per 12 months, relevant expertise, and access to clinicians and clinical samples. - OEMs and vendors: No OEMs, vendors, products, part numbers, or product quantities are identified in the provided information.

Description

National Institute of Biomedical Imaging and Bioengineering (NIBIB) Innovation Funnel Clinical Validation Core.

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