Clinical Trials Archives

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.

Certara2025年12月3日

Conference

2025 MFDS-KCDA Annual Conference

Certara2025年11月20日

Conference

PHUSE APAC Connect 2026

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Certara2025年11月20日

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 & 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…

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

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臨床試験

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

2025 MFDS-KCDA Annual Conference

PHUSE APAC Connect 2026

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

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

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

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

Dutch Medicines Days

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

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

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