Project Optimus Support

We have extensive knowledge and experience in oncology and Project Optimus requirements.

What we do

RP2D selection and defense

We have defended clients successfully in selecting their Recommended Phase 2 Dose (RP2D):

Design of Phase 1A (dose escalation) and Phase 1B (dose optimization) studies

Population PK, categorical and Exposure-Response analyses to select the RP2D

FDA Briefing Document with a strong defense of your RP2D selection

Attendance at the Type B meeting to defend your RP2D