Looking back over the last 30 years, what advance has had the greatest impact on the industry — and why?

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

Since its first mention in 2011 guidelines, risk-based quality management (RBQM) has radically reshaped clinical trials, impacting everything from trial design to the quality of outcomes, shifting organizations away from procedural checklists toward proactively identifying and addressing risks earlier. Over the last 15 years, processes and governance models have continued to develop, most recently with the latest iteration of ICH E6(R3), where risk is mentioned 87 times, moving RBQM from a “nice to have” to a regulatory expectation.

The foundation set by RBQM is becoming embedded across seven key areas, including culture, governance, organizational design, process, people, third-party partnerships, and systems and technology. While ICH E6(R3) provides regulatory support, adoption is also driven by the industry’s historical reliance on fragmented, manual processes. These processes struggle to keep pace with trial demands and stress the need for integrated quality review management to transform siloed reviews into unified, cross-functional risk oversight that improves trial outcomes. In 2026, RBQM will solidify as a core operational pillar, supported by AI integration to reimagine trial design, monitoring, and analysis processes, delivering more streamlined, accurate, and proactive insights.

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.