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 to conduct a first‑in‑human Phase 1 clinical trial comprising both single‑ascending‑dose (SAD) and multiple‑ascending‑dose (MAD) cohorts in healthy volunteers. The vendor must operate an in‑house U.S. Phase 1 clinical pharmacology unit, manage IND‑related regulatory filings, conduct intensive PK sampling, handle sample logistics to external labs, provide safety monitoring, data management, biostatistical analysis, medical writing, and full project‑management oversight. Pricing is to be milestone‑based across two NIH budget periods (minimum 24 months) with unit‑cost breakdowns for participants, cohorts, and pause/re‑activation events. The RFP is open for proposals until 3 September 2026 2:30 PM (MST). • Operate a U.S. Phase 1 clinical unit (beds, pharmacy, ACLS) and conduct FIH SAD/MAD studies with sentinel and staggered dosing. • Provide regulatory support (IRB, IND, safety reporting), 21 CFR Part 11‑compliant data capture, and extensive PK/PD sample logistics to MZBio and NorthEast Bio. • Deliver comprehensive project‑management artifacts, safety review committee packages, clinical study reports (SAD, MAD, integrated), and maintain a trial master file throughout two NIH budget periods.