Certara Services Archives

Blog

Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program

Learn how the FDA assessment aid streamlines oncology NDA/BLA reviews, what to include, and best…

Certara2026 年 3 月 17 日

Press Coverage Video

FDA Support Drives Shift Toward Bayesian Trial Design

Explore how Bayesian statistical methods are reshaping clinical trial design. Learn how FDA support, adaptive…

Danielle Pillsbury2026 年 3 月 13 日

Press Coverage

Single Pivotal Trials Demand Stronger Data and Risk Strategies

As regulators increasingly accept single pivotal trials for drug approval, sponsors must strengthen data quality,…

Certara2026 年 3 月 13 日

Blog

Advancing pharmacoequity through model-informed drug development: Insights from ASCPT 2026

Explore how model-informed drug development and AI are advancing pharmacoequity and shaping the future of…

Certara2026 年 3 月 11 日

Press Coverage Video

Advancing Bayesian Methods in Clinical Trials

Explore how Bayesian statistical methods are reshaping clinical trial design. Learn how FDA support, adaptive…

Certara2026 年 3 月 9 日

Blog

Pharmacovigilance Aggregate Reporting in China

Learn best practices for China pharmacovigilance aggregate reporting, with expert support and regulatory guidance insights.

Certara2026 年 3 月 6 日

Blog

DIA RSIDM 2026: From Doing Digital to Being Data-Driven

JTVCdGVhbV9qdW1wX2xpc3QlNUQ= 2026 年 3 月 5 日 The atmosphere at this year's DIA RSIDM conference was defined by…

Certara2026 年 3 月 5 日

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

Certara 服务

Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program

FDA Support Drives Shift Toward Bayesian Trial Design

Single Pivotal Trials Demand Stronger Data and Risk Strategies

Advancing pharmacoequity through model-informed drug development: Insights from ASCPT 2026

Advancing Bayesian Methods in Clinical Trials

Pharmacovigilance Aggregate Reporting in China

DIA RSIDM 2026: From Doing Digital to Being Data-Driven

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

Apotekarsocieteten 临床药理学策略在药物开发中的应用

文件质量和管理

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