On-Demand Webinar

Metatdata as Infrastructure: Designing for Reuse, Insight, and Auditability

Watch this on-demand webinar to learn how leading clinical teams design scalable metadata strategies that…

CertaraFebruary 26, 2026

On-Demand Webinar

Start right, finish strong: Antibody-drug conjugate (ADC) studies for success

Learn how to build regulatory-ready first-in-human (FIH) dose strategies for antibody-drug conjugates (ADCs). Discover how…

CertaraFebruary 23, 2026

Blog

FAQs: The ICH M15 guideline and what it means for model-informed drug development

Learn what the ICH M15 guideline means for Model-Informed Drug Development, regulatory credibility, harmonization, and…

CertaraFebruary 18, 2026

Blog

Pediatric drug development: From “wild west” to model-informed confidence

Model-informed drug development and precision dosing are transforming pediatric programs, from regulatory planning to Bayesian…

CertaraFebruary 11, 2026

Publication

Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants

This study, published in Clinical Pharmacology & Therapeutics (CPT), shows how population pharmacokinetic modeling supports…

CertaraFebruary 2, 2026

Blog

P21 Enterprise expands regulatory validation capabilities with support for the tobacco implementation guide v1.0

Pinnacle 21 supports TIG v1.0, the CDISC Tobacco Implementation Guide for FDA CTP, enabling automated…

CertaraJanuary 30, 2026

Blog

How model-informed drug development (MIDD) strengthens drug asset valuation and answers the questions investors care about most

Learn how Model-Informed Drug Development strengthens drug asset valuation by reducing uncertainty, predicting clinical performance,…

CertaraJanuary 26, 2026

Publication

Combining Aggregate Data and Individual Patient Data in Model-Based Meta-Analysis: An Illustrative Case Study of Tofacitinib in Rheumatoid Arthritis Patients

This article explores how model-based meta-analysis (MBMA) performs when combining aggregate data and individual patient…

CertaraJanuary 22, 2026

On-Demand Webinar

Model-Based Meta-Analysis (MBMA), Quantitative Systems Pharmacology (QSP), and Advanced Modeling in Early Reimbursement Strategy

Watch this on-demand webinar to learn how model-based meta-analysis (MBMA), quantitative systems pharmacology (QSP), and…

CertaraJanuary 22, 2026

Blog

Adaptive clinical trials in oncology: Meeting the challenge of Project Optimus

Leveraging adaptive clinical trial designs in oncology can accelerate drug development, while following the FDA…

CertaraJanuary 16, 2026

Clinical Trials

Metatdata as Infrastructure: Designing for Reuse, Insight, and Auditability

Start right, finish strong: Antibody-drug conjugate (ADC) studies for success

FAQs: The ICH M15 guideline and what it means for model-informed drug development

Pediatric drug development: From “wild west” to model-informed confidence

Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants

P21 Enterprise expands regulatory validation capabilities with support for the tobacco implementation guide v1.0

How model-informed drug development (MIDD) strengthens drug asset valuation and answers the questions investors care about most

Combining Aggregate Data and Individual Patient Data in Model-Based Meta-Analysis: An Illustrative Case Study of Tofacitinib in Rheumatoid Arthritis Patients

Model-Based Meta-Analysis (MBMA), Quantitative Systems Pharmacology (QSP), and Advanced Modeling in Early Reimbursement Strategy

Adaptive clinical trials in oncology: Meeting the challenge of Project Optimus

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