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Project Optimus Support
We have extensive knowledge and experience in oncology and Project Optimus requirements. We have defended clients successfully in selecting their RP2D:
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Design your Phase 1A (dose escalation) and Phase 1B (dose Optimization) studies
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Perform the population PK, categorical and Exposure-Response analyses needed to select the RP2D
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Write the FDA Briefing Document including a strong defense of your RP2D selection
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Attend the Type B meeting to defend your RP2D
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