Clinical Research Support for Tropical Fever Diagnostic Evaluation

Description

{"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: \n\n Project Management: Provide qualified personnel for all roles, including Principal Investigator(s), clinical staff, phlebotomists, laboratory technicians, and administrative support. \n\n 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. \n\n Patient Enrollment: Screen, consent, and enroll approximately 300 patients who present with clinical suspicion of tropical fever, following the IRB-approved protocol. \n\n Sample Collection & Processing: Collect venous and capillary blood samples from enrolled patients. \n\n Diagnostic Testing: Perform on-site testing using the Government-furnished GeneXpert Edge X system. \n\n Comparator Analysis: Perform comparator testing using the Biofire Global Fever Panel and conduct discrepant analysis via sequencing. \n\n Data Management: Ensure accurate and timely data entry, quality assurance, and secure storage of all study data. \n\n Reporting: Provide regular monthly status reports, teleconference updates, and other deliverables as required to NAMRU EURAFCENT. \n\n See attached Sources Sought for further details. \n"} Solicitation Number: SS-NAMRU-258C2 Type: Sources Sought Base Type: Sources Sought NAICS: 541715 Classification Code: AN42 Response Deadline: 2026-03-12T14:00:00+01:00 Office Address: FPO, AE POC: Terry Herbert, terry.l.herbert3.civ@us.navy.mil, +1 771-235-3160 {"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: \n\n Project Management: Provide qualified personnel for all roles, including Principal Investigator(s), clinical staff, phlebotomists, laboratory technicians, and administrative support. \n\n 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. \n\n Patient Enrollment: Screen, consent, and enroll approximately 300 patients who present with clinical suspicion of tropical fever, following the IRB-approved protocol. \n\n Sample Collection & Processing: Collect venous and capillary blood samples from enrolled patients. \n\n Diagnostic Testing: Perform on-site testing using the Government-furnished GeneXpert Edge X system. \n\n Comparator Analysis: Perform comparator testing using the Biofire Global Fever Panel and conduct discrepant analysis via sequencing. \n\n Data Management: Ensure accurate and timely data entry, quality assurance, and secure storage of all study data. \n\n Reporting: Provide regular monthly status reports, teleconference updates, and other deliverables as required to NAMRU EURAFCENT. \n\n See attached Sources Sought for further details. \n"}