Certara Talks – Pivotal Trial Mandate
Explore how the FDA’s shift toward one pivotal trial plus supporting evidence could reshape drug…
CertaraApril 22, 2026
Extending the Value of Antibody–Drug Conjugates: Model-Informed Labeling, Expansion, and Market Access
Learn how model-informed strategies support ADC labeling, dose optimization, and market access through integrated evidence…
CertaraApril 10, 2026
How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer
HUTCHMED was preparing a New Drug Application (NDA) submission for FRUZAQLA® (fruquintinib) a drug developed…
CertaraApril 7, 2026
Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib
This study demonstrates how a model-informed, totality-of-evidence approach was used to select the optimal clinical…
Danielle PillsburyApril 2, 2026
How Bayesian Design Is Reshaping Clinical Development
Learn how Bayesian design is reshaping clinical trials with adaptive methods that improve efficiency, reduce…
CertaraMarch 27, 2026
Shaping the Future of Medical Writing: Key Themes for 2026
Five key themes and their implications for leaders shaping their Medical Writing strategy for 2026
CertaraMarch 26, 2026
