Integrate quantitative insights with our expertise to de-risk clinical trial design
Design your next clinical trial with intention using MIDD. De-risk the trial design with clinical trial simulations to calibrate your expectations and understand the probability of success before dosing a single participant. Our team leverages data-driven understanding of key drug characteristics, real quantitative insights, and deep knowledge of regulatory processes to shape decision-making around dose regimens, sampling times, inclusion/exclusion criteria, and critical study design considerations to support your regulatory submissions.
What's included
- Strategy and guidance
- Pharmacometric support
- Document authorship/co-authorship
Project Optimus
Align your oncology program with the goals of FDA Project Optimus
Translational modeling for FIH dose selection
Leverage a quantitative approach to first-in-human (FIH) dose selection
Pharmacokinetic and pharmacodynamic modeling and simulation
Quantitative models to describe and predict your drug’s PK and resulting PD response
Exposure-response modeling of efficacy and safety
Quantitative models to describe and predict your drug’s efficacy and safety
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