Clinical Research Support for Tropical Fever Diagnostic Evaluation
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Department of the Navy / NAVSUP FLC SIGONELLA NAPLES OFFICE is conducting market research via a Sources Sought notice for Clinical Research Support for Tropical Fever Diagnostic Evaluation. This effort seeks qualified businesses to provide non-personal services for a clinical study at the Komfo Anokye Teaching Hospital (KATH) in Ghana. The information gathered will inform the Government's acquisition strategy. Responses are due March 12, 2026, at 2:00 PM Central European Time (CET).
Scope of Work
The contractor shall provide all personnel, equipment, supplies, facilities, and other non-personal services necessary to execute a clinical study titled "Clinical evaluation of the Xpert® tropical fever test on the Genexpert® Edge X system." Key tasks include:
- Project Management: Providing qualified personnel (Principal Investigator, clinical staff, phlebotomists, lab technicians, administrative support).
- Regulatory Compliance: Obtaining and maintaining local IRB approvals, ensuring Good Clinical Practice (GCP) adherence, and managing study documentation.
- Patient Enrollment: Screening, consenting, and enrolling approximately 300 patients with suspected tropical fever.
- Sample Collection & Processing: Collecting venous and capillary blood samples.
- Diagnostic Testing: Performing on-site testing using Government-furnished GeneXpert Edge X system.
- Comparator Analysis: Conducting comparator testing with the Biofire Global Fever Panel and discrepant analysis via sequencing.
- Data Management: Ensuring accurate data entry, quality assurance, and secure storage.
- Reporting: Providing monthly status reports and teleconference updates to NAMRU EURAFCENT.
Contract & Timeline
- Type: Sources Sought / Market Research
- Anticipated Period of Performance: One (1) 12-month base year with one (1) 6-month option period.
- Place of Performance: Komfo Anokye Teaching Hospital (KATH), Ghana.
- Set-Aside: None specified.
- Response Due: March 12, 2026, 2:00 PM CET.
- Published: February 25, 2026.
Submission & Evaluation
Interested parties must submit a capability statement not exceeding 10 pages. Statements should address:
- Company Profile: Name, address, POC, UEI, CAGE, business size.
- Past Performance: Up to 3 relevant projects within the last 5 years, emphasizing infectious disease clinical trials, in vitro diagnostic device evaluations, and research experience in Ghana/West Africa.
- Technical & Management Capability: Personnel recruitment, facilities access, regulatory expertise with Ghanaian IRBs and GCP, and logistics management in Ghana. Submissions should be emailed to the specified points of contact with the subject line "Response to Sources Sought Notice: SS-NAMRU-258C2 - [Your Company Name]". This notice is for informational and planning purposes only and does not constitute a solicitation.
Government-Furnished Items
The Government will provide the GeneXpert machine, associated test kits and cartridges, and supplies for sample collection and shipping.