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 Pillsbury2026 年 3 月 4 日

Conference

Apotekarsocieteten 临床药理学策略在药物开发中的应用

Danielle Pillsbury2026 年 3 月 2 日

Fact Sheet

文件质量和管理

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

Certara2026 年 2 月 27 日

Fact Sheet

安全性与药物警戒撰写

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

Certara2026 年 2 月 27 日

博客

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…

Certara2026 年 2 月 26 日

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…

Certara2026 年 2 月 26 日

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…

Certara2026 年 2 月 13 日

Guide

EMA Policy 0070 Submission Readiness Checklist

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

Certara2026 年 2 月 12 日

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…

Certara2026 年 2 月 11 日

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…

Certara2026 年 2 月 2 日

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