Clinical Research Support for Tropical Fever Diagnostic Evaluation

The contractor shall provide all personnel, equipment, supplies, facilities, and other non-personal services necessary to execute the clinical study at the Komfo Anokye Teaching Hospital (KATH) in Ghana. Key tasks include, but are not limited to:

Project Management: Provide qualified personnel for all roles, including Principal Investigator(s), clinical staff, phlebotomists, laboratory technicians, and administrative support.

Regulatory Compliance: Obtain and maintain all necessary approvals from the local Institutional Review Board (IRB), ensure adherence to Good Clinical Practice (GCP), and manage all study documentation.

Patient Enrollment: Screen, consent, and enroll approximately 300 patients who present with clinical suspicion of tropical fever, following the IRB-approved protocol.

Sample Collection & Processing: Collect venous and capillary blood samples from enrolled patients.

Diagnostic Testing: Perform on-site testing using the Government-furnished GeneXpert Edge X system.

Comparator Analysis: Perform comparator testing using the Biofire Global Fever Panel and conduct discrepant analysis via sequencing.

Data Management: Ensure accurate and timely data entry, quality assurance, and secure storage of all study data.

Reporting: Provide regular monthly status reports, teleconference updates, and other deliverables as required to NAMRU EURAFCENT.

See attached Sources Sought for further details.