Selecting the optimal dose and trial design for Phase 3 can be challenging when clinical evidence is limited. In this case study, a pharmaceutical company developing a novel rheumatoid arthritis therapy partnered with Certara to apply model-based meta-analysis (MBMA) using Phase 2 and external clinical trial data. By integrating efficacy and safety data, accounting for key patient covariates, and simulating multiple Phase 3 scenarios, Certara helped identify the optimal development strategy before initiating a pivotal trial. The resulting evidence improved confidence in dose selection, informed competitive positioning, and reduced development risk while accurately predicting Phase 3 outcomes.
“MBMA provided clarity and confidence to design a successful Phase 3 trial—using only Phase 2 data and external evidence.”
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Ready to reduce uncertainty in your next development program? Connect with Certara’s MBMA experts to learn how model-based meta-analysis can strengthen Phase 3 planning and accelerate confident decision-making.
