Expedited Study Delivery - Logistics

A biotech Sponsor approached QPS to conduct a challenging Phase I SAD/MAD study, involving multiple IV doses over multiple days in healthy volunteers.  The design included first-in-human, safety, tolerability and PK of multiple escalating IV infusion doses. The study subjects received multiple infusions of study drug, during daytime and nightime hours, on each study day.

This case study outlnes the 3 factors that allowed QPS to deliver a complex, data-intensive early phase clinical trial, and collected approximately 1,000,000 data points in just 2 months.