Which digital technologies have delivered tangible operational value over the past 12–18 months and which remain over-hyped?

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

Over the past year, sponsors have been increasingly adopting risk-based quality management (RBQM) for their trials amid new regulatory frameworks, such as ICH (E6) R3, which emphasizes risk-proportionate approaches according to criticality of data and proactive quality by design. When the FDA recently shifted toward a single trial paradigm for drug approvals, this increased pressure on sponsors to strengthen evidence before regulatory submission. These changes are encouraging sponsors to rethink trial design, accelerating the deployment of data intelligence platforms that support integrated quality risk management (IQRM) approaches to RBQM and centralized monitoring, augmented by AI, to provide risk-based data review and quality management for oversight of the entire portfolio, mitigating risk across the trial life cycle. Tangible operational value has included measurable return on investment (ROI) through efficiency gains, quicker issue resolution, quality, and regulatory compliance.

Embedded AI capabilities add a layer of support by reducing manual labor, analyzing large data sets, and proactively flagging risks so that trial teams can take necessary action to resolve issues. It’s critical that AI be seamlessly integrated into existing workflows with specific use cases and demonstrable success, to ensure the technology doesn’t get over-hyped, and to drive breakthrough treatments, getting lifesaving drugs to patients safely, faster.

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.