Maximize your understanding of your anti-cancer drug’s safety and efficacy profile to achieve regulatory and commercial success with Certara’s strategic and technology-enabled services across the entire drug development continuum – from pre-clinical first-in-human studies to regulatory submissions, health economics/outcomes research and market access value communication.
Certara® the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, announced today that it has appointed Dr. William F. Feehery as its new Chief Executive Officer (CEO) and a member of the Certara Board of Directors, effective June 3, 2019.
Advanced Analytics Using RWD Can Mitigate Risks in AD Drug Development, Reimbursement and Utilization
June 6, 2019 – This webinar will explain how advanced analytics using real-world data can mitigate challenges in Alzheimer’s disease drug approval, reimbursement and utilization.
May 29, 2019 – This webinar explores a new version of a 21 CFR Part 11 compliant data repository that significantly improves the clinical pharmacology workflow.
This blog reviews trends for using health economics and outcomes research and real-world evidence to evaluate the value of medicines and health technologies.
May 22, 2019 – This webinar will discuss how Certara’s PBPK platform, the Simcyp® Simulator, was used to assess the risk-benefit profile for ethinylestradiol, the estrogen component of most combined oral contraceptives.
Population Pharmacokinetic Analysis of DS-8201a, A HER2-Targeting Antibody-Drug Conjugate, in Patients with HER2-Positive Breast Cancer or Other Solid Tumors
QSP can inform designing First-in-Human clinical trials to help determine the starting dose and subsequent dose escalations to ensure human subject safety.