As we know, PV teams are facing increasing pressure as safety reporting volumes continue to rise and regulators demand greater consistency and transparency. Against this backdrop, Parexel is making a significant investment in AI-driven automation.

The appeal of Vitrana’s platform lies in its ability to move beyond basic workflow support and automate substantial portions of the PV process itself. The system can automate case intake, data extraction, entity mapping, reconciliation, and narrative generation.

According to Parexel President Sanjay Vyas, the partnership has already delivered a 60% reduction in case processing times and a 75% decrease in manual reconciliation work across more than 30 customer deployments. This is particularly significant because reconciliation remains one of the most labour-intensive aspects of safety operations, with many PV teams spending considerable time checking consistency across multiple systems, narratives, and reporting databases. Reducing this burden could free up valuable resources for higher-value safety activities.

This move aligns with Parexel’s broader AI strategy. Over the past two years, the company has invested in AI-powered regulatory submissions, real-time clinical infrastructure, and AI-enabled clinical planning and execution platforms. It has also strengthened its relationships with regulators and digital health partners as the FDA increasingly explores continuous, data-driven clinical trial models.