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, via the Arizona Board of Regents, is seeking a qualified Contract Research Organization (CRO) to conduct a Phase 1 first‑in‑human clinical trial program comprising single‑ascending‑dose (SAD) and multiple‑ascending‑dose (MAD) cohorts in healthy volunteers. The vendor must own and operate a U.S. Phase 1 clinical pharmacology unit, manage IND‑related regulatory submissions, conduct intensive PK/PD sampling, handle sample logistics to external labs, provide safety monitoring via a Safety Review Committee, and deliver comprehensive data management, biostatistical analysis, medical writing, and project‑management deliverables across two NIH budget periods. The work is milestone‑based, with detailed unit‑cost pricing required, and the contract includes provisions for pauses, re‑activations, and possible month‑to‑month extensions. • Operate an in‑house Phase 1 clinical unit with beds, investigational‑drug pharmacy, and ACLS capability. • Conduct FIH SAD (up to 40 participants) and MAD (up to 24 participants) studies, including sentinel and staggered dosing, intensive PK sampling, and rigorous safety monitoring. • Manage all regulatory aspects (IRB, IND, FDA safety reporting), sample logistics to MZBio and NorthEast Bio, data management (21 CFR Part 11‑compliant EDC), biostatistics, medical writing, and project‑management deliverables.