About this opportunity
AI summaryThe National Institute of Biomedical Imaging and Bioengineering seeks capability statements from qualified sources to establish a Clinical Validation Core for its Innovation Funnel. The core will provide technical, analytical, human factors, and clinical validation services, including protocols, laboratory equipment, BioSafety Level 2 or greater facilities, and clinical sample collection and storage to evaluate prototype diagnostic devices. All qualified sources may respond by detailing their experience, personnel qualifications, laboratory facilities, and ability to conduct at least 50 validation studies within 12 months. Capability statements must not exceed five pages, excluding CVs and past performance appendices, and must use a minimum 12-point font. Responders must submit statements electronically in MS Word or PDF format to Contract Specialist Noelle DeCenzo and Contracting Officer Melanie Suarez by December 4, 2026, at 12:00 PM ET.
Scope of work
- Standard processes to develop protocols for conducting analytical and clinical validation studies of diagnostic devices
- Templated validation reports providing critical feedback to device developers
- Technical and clinical expertise in diagnostic device evaluation and laboratory capabilities
- All required laboratory equipment to complete analytical and clinical validation studies
- BioSafety Level 2 (or greater) facilities
- Sites for collection of human clinical samples, usability and human factors testing, and related measurements
- Facilities and resources for storage of human clinical samples
- IT systems and support for data management and reporting, plus legal services for NDA and MTA policies
Minimum qualifications
- Documented experience with similar large-scale project requirements in the past three years
- Established process to collaborate with inventors and regulatory experts on diagnostic testing protocols
- Ability to conduct at least 50 analytical and/or clinical validation studies during a 12-month period
- Access to and experience with BioSafety Level 2 (or greater) facilities
- Access to a network of clinicians across medical diagnostics specialties
- Ability to prospectively collect human clinical samples and other relevant measurements
- Experience managing and overseeing a clinical sample repository or biobank
- Up-to-date knowledge of FDA regulatory guidance for the diagnostic industry
Documents to include with your response
- Capability statement addressing each project requirement separately
- List of projects for the past three years
- CVs detailing professional qualifications of technical/medical experts, entrepreneurs, and business experts
- Description of general and specific facilities and equipment currently available, including computer equipment and software
- Company name, address, website, point of contact name, email, and phone number
- Current GSA Schedule Contracts as applicable
- Company type as shown in SAM
- UEI (formerly DUNS) number
Key dates
- Responses due
- December 4, 2026, at 12PM ET
How to submit
- Method
- Instructions
- Submitted electronically via email in MS Word or Adobe PDF; must not exceed 5 pages excluding CVs and past performance (as an Appendix); 12-point font size minimum.
Contract details
- Funding
- NIH Rapid Acceleration of Diagnostics (RADx) Initiative
Federal notice details
- Solicitation number
- 75N98027R00015
- Agency
- Department of Health and Human Services
- Buying office
- National Institutes of Health › National Institutes of Health Olao
- Notice type
- Sources Sought
- Responses due
- Dec 4, 2026, 12:00 PM ET
- Posted on SAM.gov
- Nov 3, 2026
- NAICS
- 541618 · Other Management Consulting Services
- Product/service code
- R410
- Contracting contact
- SUAREZ, MELANIE D
melanie.suarez@nih.gov
+1 000 000 0000
Source: SAM.gov. Read the official notice for the complete description and current instructions.
Incumbent and award research
No incumbent history found for this requirement. The notice does not cite a current contract, and no earlier award from this buying office matches it.
Market context
Awards in the same category (Other Management Consulting Services). This is not this requirement's award history.
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