U.S. International Reference Pricing: Global Implications and Pharma Strategy
Unintended global fallout of international reference pricing: How the U.S. Most Favored Nation policy could…
CertaraOctober 6, 2025
Essentials of Model-informed Drug Development in Oncology
Model-informed drug development in oncology is critical to developing safer and more effective cancer drugs.…
CertaraOctober 6, 2025
Highlights from the FDA Guidance on Dosage Optimization for Therapeutic Radiopharmaceuticals
Learn how radiopharmaceutical therapies work in oncology and how Certara supports development with modeling, simulation,…
CertaraOctober 3, 2025
C-QTc and C-QT Analysis: Replacing TQT Studies and Accelerating Cardiovascular Safety Decisions
Replace TQT studies with validated C-QT analysis strategies accepted by FDA, EMA, PMDA. Learn more…
CertaraOctober 3, 2025
How Certara and TrialAssure Partner to Deliver Faster, Compliant Anonymization for Global Sponsors
Discover how Certara's partnership with TrialAssure provides global sponsors with accelerated, compliant, and enhanced document…
CertaraOctober 3, 2025
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
Preparing for the Operational Burden of OS Requirements in Oncology Trials
Ananth Kadambi outlines how clinical operations teams can plan for FDA’s OS requirements—enhancing patient tracking…
CertaraSeptember 26, 2025
How RWE and Predictive Modeling Support OS-Focused Trial Designs
Discover how real-world evidence and predictive modeling strengthen OS-focused trial designs in oncology, improving efficiency…
CertaraSeptember 25, 2025
Using Model-Informed Drug Development to Support OS Endpoints
Ananth Kadambi shares how model-informed drug development helps sponsors predict efficacy and align shorter oncology…
CertaraSeptember 24, 2025
