Accelerated FDA approval by 4 months for a major oncology compound in Phase three global clinical trial valued at $1.3M in daily sales.
Accelerated FDA approval by 4 months for a major oncology compound in Phase three global clinical trial valued at $1.3M in daily sales.
A Global Phase 3 oncology study was running six months behind schedule, jeodardizing approvals for a new compound that was shown to dramatically reduce non-small cell lung cancer tumors. The companies elevated share price reflected the markets confidence in meeting the original submission date announced by its CEO. Yet the new study team lacked certainty in clawing back any of the 6 months projected delay.
HIP was asked to design an intervention with the Global study team, physicians, site staff and study monitors in order to pro-actively address the delay and produce a turn around.
Working session were conducted with the study team, data management, Investigators and Monitors to:
The joint breakthrough team produced an on-time database lock and successfully clawed back 4 months from the 6-month approval delay. Sales estimated at $1.3 M per day.