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 PillsburyNovember 12, 2025

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…

CertaraNovember 5, 2025

On-Demand Webinar

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

Watch this on-demand webinar to learn how pharmacometrics supports NDA, BLA, and global regulatory submissions.…

CertaraNovember 3, 2025

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…

CertaraOctober 31, 2025

On-Demand Webinar

AAPS Webinar – Pediatric Drug Development: Why It’s Critical to Submission Strategy and How Modeling, Regulatory, and Clinical Insights Shape Success

Learn how model-informed drug development, clinical pharmacology, and regulatory strategy support successful pediatric drug development…

CertaraOctober 21, 2025

Conference

Dutch Medicines Days

CertaraOctober 7, 2025

Case Study

Certara & Dizal Partner to Fast-Track FDA Approval of Sunvozertinib for Lung Cancer

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

CertaraOctober 2, 2025

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…

CertaraSeptember 22, 2025

Blog

FAQs on Developing EMA Policy 0070 Submissions

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

CertaraSeptember 15, 2025

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…

CertaraSeptember 11, 2025

Clinical Trials