Case Study

Smart Start-Up: Combining Streamlined Processes & Leading Edge Technology

Source: goBalto
Smart Start-Up: Combining Streamlined Processes & Leading Edge Technology

A leading global contract research organization was contracted to conduct a two phase global oncology trial on behalf of a mid-sized Pharma company. The study was comprised of both phase I (dose finding and dose confirmation) and phase II (dose expansion) components. The original goal was to activate 20-25 sites for the phase I component and an additional 55 sites to be on boarded for phase II. By the time the protocol was received, sites had been selected and the First Site Initiation Visit (FSIV) was targeted to occur in less than five months. The core regulatory pack was due for finalization within 11 days of receipt of the protocol.