Clinical Trials 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

Blog

ADC 首次人体（FIH）剂量选择：成功设计 FIH 研究的关键

Optimize ADC First-in-Human Dose Selection with model-informed strategies and exposure–response insights to design safer, more…

Certara2026 年 3 月 3 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

Blog

From Documentation to Design: Building a Scalable Metadata Strategy for Clinical Research

Learn how clinical teams are treating metadata as infrastructure to improve reuse, auditability, and standards…

Certara2026 年 2 月 26 日

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…

Certara2026 年 2 月 26 日

On-Demand Webinar

Start right, finish strong: 抗体-药物偶联物（ADC）研究成功之道

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

Certara2026 年 2 月 23 日

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…

Certara2026 年 2 月 18 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

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…

Certara2026 年 1 月 30 日

临床试验

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

ADC 首次人体（FIH）剂量选择：成功设计 FIH 研究的关键

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

From Documentation to Design: Building a Scalable Metadata Strategy for Clinical Research

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

Start right, finish strong: 抗体-药物偶联物（ADC）研究成功之道

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

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