Request for proposal for Phase 1 Clinical Trials - First-in-Human Single and Multiple Ascending Dose (SAD/MAD) Study in Healthy Volunteers

The University of Arizona is seeking a qualified CRO to conduct a Phase 1 first‑in‑human (FIH) single‑ascending‑dose (SAD) and multiple‑ascending‑dose (MAD) study of investigational peptide PNA5 in healthy volunteers. The vendor must operate a U.S. Phase 1 clinical pharmacology unit, manage all aspects of study conduct—including participant recruitment, dosing, intensive PK sampling, safety monitoring, IRB submissions, and regulatory reporting—and coordinate sample logistics with external bioanalysis labs. The contract is milestone‑based across two NIH budget periods (each 12 months) with optional three‑month extensions, and requires detailed deliverables such as safety review packages, PK data integration, clinical study reports, and a complete trial master file. • Own and operate a Phase 1 clinical unit with ACLS capability and beds. • Execute SAD (up to 40 participants, 5 cohorts) and MAD (up to 24 participants, 3 cohorts) protocols, including sentinel and staggered dosing. • Provide 21 CFR Part 11‑compliant EDC, biostatistical analysis, safety review committees, and full documentation (IRB, TMF, CSR). • Manage sample logistics to MZBio (PK) and NorthEast Bio (immunogenicity) with chain‑of‑custody and rapid turnaround.