Certara Services Archives

Publication

Model-Based Meta-Analysis of Objective Response Rate and Survival Endpoints to Compare PD-1 and PD-L1 Treatment Outcomes in Non-Small Cell Lung Cancer

This study used model-based meta-analysis (MBMA) to assess how well objective response rate (ORR) predicts…

Danielle PillsburyMarch 4, 2026

Conference

Apotekarsocieteten Clinical Pharmacology Strategies in Drug Development

Danielle PillsburyMarch 2, 2026

Fact Sheet

Document Quality and Management

Ensure submission readiness with Certara’s Document Quality services. We deliver compliant, inspection-ready regulatory documents that…

CertaraFebruary 27, 2026

Fact Sheet

Safety & Pharmacovigilance Writing

Expertly delivering Safety & Pharmacovigilance Writing services, including Aggregate Safety Reports, Risk Management Plans, and…

CertaraFebruary 27, 2026

Blog

Rare Disease Day 2026: Accelerating Rare Disease Drug Development Through Cross-Functional Innovation

On Rare Disease Day 2026, Certara experts share how cross-functional innovation, regulatory strategies for rare…

CertaraFebruary 26, 2026

Press Release

Certara Reports Fourth Quarter 2025 Financial Results; Provides Full Year 2026 Guidance

FY 2025 Revenue of $418.8M (9% growth) and Adj. EBITDA of $134.5M (10% growth) Fourth…

CertaraFebruary 26, 2026

Guide

Guided by Evidence: Implementing the ICH M15 Guideline for Model-Informed Drug Development (MIDD)

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

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