Certara Services Archives

Guide

Guided by Evidence: Preparing for ICH M15 and the Next Evolution of Model-Informed Drug Development

Prepare for ICH M15 guideline: Learn how to assess model credibility, align terminology, and strengthen…

CertaraFebruary 13, 2026

Guide

EMA Policy 0070 Submission Readiness Checklist

Use this EMA Policy 0070 Submission Checklist to prepare compliant clinical data packages, manage anonymization…

CertaraFebruary 12, 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

Press Coverage

Opinion: To Accelerate Rare Disease Progress, Take a Sandbox Approach

Explore how a collaborative “sandbox” approach—combining flexible regulation, data modeling, and stakeholder engagement—can transform rare…

CertaraJanuary 30, 2026

Conference

AI in Drug Discovery 2026

CertaraJanuary 30, 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

Webinar

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

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

Webinar

CHI ADC Webinar Series: From First-in-Human Dose Selection to Label Optimization, Commercial Expansion, and Market Access

CertaraJanuary 14, 2026

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