From Two Trials to One, Sponsors Face a Higher Standard

In this episode of Denatured, you'll listen to Oxana Iliach, senior director of regulatory strategy at Certara and Vera Pomerantseva, director of product management for risk-based quality management at eClinical Solutions. We speak about how the FDA's latest decision to have one, rather than two pivotal studies, for new drug applications raises the bar for data collection and risk-based management.Host⁠Jennifer C. Smith-Parker⁠, Director of Insights, BioSpaceGuestsOxana Iliach, Senior Director of Regulatory Strategy, CertaraVera Pomerantseva, Director of Product Management for RBQM, eClinical SolutionsDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.