Certara Model-Based Meta-Analysis (MBMA) helps to address important drug development questions around competitive landscaping, appropriate differentiation targets, and optimal trial design. MBMA enables indirect comparisons of safety and efficacy, taking into account the impact of treatment, dose, effect onset, and patient and trial characteristics. Unlike traditional meta-analysis approaches, Certara MBMA projects use our CODEX Outcomes Databases, which capture up-to-date information on trial design, patient characteristics, and outcomes (safety and efficacy) from clinical trials in more than 60 indications.
Model-Based Meta-Analysis
Harnessing the power of published clinical data with modeling and simulation
Applying predictive models and synthetic controls based on highly curated clinical trial data to inform critical drug development decisions.
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Transform data into strategic insights
Achieve more accurate trial comparisons
Create synthetic control arms to mimic specific trial populations and more appropriately compare treatment effects, delivering reliable results that reduce dependence on traditional observational methods.
Uncover new insights across studies
Go beyond head-to-head clinical trials. With MBMA, compare treatments and explore patient groups that haven’t been directly tested together for new, broader insights.
Leverage diverse data for smarter strategies
Tap into rich longitudinal outcomes data with pharmacologic models that incorporate critical effect modifiers, informing impactful data-driven strategies.
Certara expertise
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Probability of success & target product profile
Identify surrogate endpoints to improve dose selection confidence, reducing Phase 3 risks. Define differentiation targets based on the competitive landscape and published data, and support dose selection for new indications by correlating responses across indications.
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Market access, business development & go/no-go decisions
Leverage data driven strategies to demonstrate product value, secure market access, and benchmark single-arm trial responses for Phase 2 and Phase 3 go/no-go evaluations. Compare efficacy and safety of in-licensing opportunities to competitors to assess technical and regulatory success probabilities.
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Proven leaders in MBMA
With decades of drug development expertise and cutting-edge methodologies, Certara stands as a global leader in MBMA. Our team of distinguished scientists and clinical data experts ensures your drug development is backed by both innovation and precision.
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专家
Jaap Mandema, PhD
Senior Distinguished Scientist
Jaap 主要经验在于应用建模和模拟来优化治疗策略、试验设计和药物开发决策。He is the world’s leading expert on model-based meta-analysis and has published extensively and received several awards for his academic contributions.
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专家
Matt Zierhut, PhD MBA
Vice President, MBMA Capability Lead, Certara Drug Development Solutions
Matt advances the integration of published clinical outcomes data into development decisions and commercial and regulatory strategy via model-based meta-analysis (MBMA). Matt 与临床开发团队密切合作，确保在做出最关键决策的时候，能利用 MBMA 发挥最佳影响力。
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It’s time to elevate your approach to drug development. Whether you’re optimizing trial design or seeking strategic insights, Certara’s MBMA delivers the clarity and competitive edge you need to thrive. With proven methodologies and a commitment to innovation, we’re your trusted partner in achieving clinical success.
Make Confident Decisions – Optimize trial design, assess competitors, and enhance regulatory strategies with curated clinical data.
Reduce Trial Risk – Use synthetic control arms to improve accuracy and reduce reliance on traditional methods.
Gain a Competitive Edge – Go beyond head-to-head trials for smarter comparisons and better success rates.
Expert-Driven Innovation – Leverage Certara’s MBMA expertise to accelerate drug development.
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常见问题解答
What is model-based meta-analysis (MBMA)?
MBMA is a technique that uses pharmacology models and curated clinical trial data to derive insights across multiple studies, including creating synthetic control arms.
How does MBMA support drug development?
It enables comparative analysis, optimizes trial design, and provides actionable insights for go/no-go decisions and portfolio management.
What datasets does Certara use for MBMA?
Certara’s MBMA leverages the Clinical Trial Outcomes Databases, covering over 45 therapeutic areas.
