Clinical Trials Archives

Fact Sheet

Strategic Project Management for Accelerated Drug Development

Expert project leadership to keep complex programs on track, aligned, and moving forward—so you can…

CertaraDecember 23, 2025

Publication

A Systematic Review and Model-Based Meta-Analysis of Pegylated-Interferon-α-Induced HBsAg Loss in Chronic Hepatitis B Virus Infection

This study synthesizes data from a large body of clinical trials to evaluate rates of…

CertaraDecember 18, 2025

Case Study

Merck Advances Pediatric Oncology with Innovative ADC Modeling

Merck leveraged ADC modeling and pediatric ADC dose optimization to enable FDA acceptance and advance…

CertaraDecember 12, 2025

Fact Sheet

Expedited Pharmacometrics Regulatory Submissions

Certara delivers complete, compliant pharmacometric regulatory submission packages in just 4–6 weeks, eliminating the PMx…

CertaraDecember 8, 2025

Announcement

Certara Cuts Pharmacometrics Submission Timelines in Half: New Expedited Service Accelerates Global Regulatory Filings

Certara launches an expedited Pharmacometrics (PMx) Regulatory Submission service that cuts submission timelines in half.

CertaraDecember 3, 2025

Conference

2025 MFDS-KCDA Annual Conference

CertaraNovember 20, 2025

Conference

PHUSE APAC Connect 2026

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CertaraNovember 20, 2025

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

Clinical Trials