Clinical Research Support for Tropical Fever Diagnostic Evaluation

Description

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.