# SAM #75N98027R00015

NIBIB Clinical Validation Core Capability Request

**Buyer:** NIH Office of Logistics and Acquisition Operations
**Posted:** November 03, 2026
**Respond By:** December 04, 2026
**Identifier:** 75N98027R00015
**NAICS:** 541618, 541715, 541714, 621512

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.

[View original listing](https://sam.gov/opp/0e86fc6ca3ee4a43937c38ff84b556cc/view)