From Two Trials to One, Sponsors Face a Higher Standard

Jennifer C. Smith-Parker, Vera Pomerantseva

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.

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In this Denatured episode, Jennifer C. Smith-Parker speaks 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 discuss about how the FDA’s move from two to one pivotal study for new drug applications sets a higher benchmark for data collection and risk-based management.

Host

⁠Jennifer C. Smith-Parker⁠, Director of Insights, BioSpace

Guests

Oxana Iliach, Senior Director of Regulatory Strategy, Certara

Vera Pomerantseva, Director of Product Management for RBQM, eClinical Solutions

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Vera Pomerantseva

Director of Product Management, RBQM, eClinical Solutions

Vera Pomerantseva is a clinical research and risk management leader with extensive experience in risk-based quality management (RBQM), clinical data analytics, and quality strategy. As Director of Product Management for RBQM at eClinical Solutions, she leads the vision and development of data-driven solutions that help life sciences organizations proactively identify risk, improve trial quality, and drive operational excellence. Vera brings deep industry experience from leadership roles at ZS, Bristol-Myers Squibb, and Novartis, and is widely recognized for her thought leadership in applying risk-based methodologies and quality-by-design principles to clinical development.