Clinical Trials Archives

Case Study

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

To accelerate the first oral therapy for hereditary angioedema (HAE), KalVista Pharmaceuticals partnered with Certara…

Danielle Pillsbury2025 年 11 月 12 日

Publication

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

This study demonstrates how model-informed approaches can improve dose selection decisions when direct clinical comparisons…

Certara2025 年 11 月 5 日

Webinar

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

Danielle Pillsbury2025 年 11 月 3 日

Publication

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

Bridge across studies with Model-based Meta Analysis, incorporating broader data & synthetic patients to enhance…

Certara2025 年 10 月 31 日

Conference

Dutch Medicines Days

Certara2025 年 10 月 7 日

Case Study

Certara 与迪哲强强联手助力舒沃替尼斩获FDA肺癌适应症加速批准

Certara’s support enabled fast-track FDA oncology approval 2025 for Sunvozertinib, a breakthrough NSCLC therapy targeting…

Certara2025 年 10 月 2 日

Announcement

Certara Launches DIDB® Concomitant Meds Navigator, Extending Leadership in Drug Interaction Science

Meet DIDB Concomitant Meds Navigator—an evidence-based tool to identify contraindicated or monitored co-medications and manage…

Certara2025 年 9 月 22 日

Blog

制定 EMA 政策0070 提交材料的常见问题解答

This blog answers audience questions posed during our RAPS webinar, How to Plan for a…

Certara2025 年 9 月 15 日

Guide

The Top 10 Things You Need to Know About ADNCA Datasets

Learn how ADNCA datasets can modernize non-compartmental analysis: enhanced compliance, automations, and faster PK data…

Certara2025 年 9 月 11 日

Conference

Redefining Every Stage of Investment (RESI) Seed to Exit

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Certara2025 年 9 月 5 日

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