Case Study: PRAC-EMA achieves 100% identification of missed pregnancy exposures and meets audit deadlines with IQVIA Vigilance Detect

PRAC-EMA - Customer Case Study

PRAC-EMA discovered that a client had overlooked pregnancy cases in their safety database and gave the client 30 days to audit and report any missed pregnancy exposure events. The client engaged IQVIA to support a retrospective review across 91 products using IQVIA’s Vigilance Detect.

IQVIA rapidly configured Vigilance Detect to automatically identify potential pregnancy and exposure cases and deployed pharmacovigilance specialists to validate the outputs. In 30 days IQVIA reviewed 855,121 cases across 91 products, achieved 100% accuracy, reduced manual effort by 96%, identified true pregnancy-exposed cases in 9% of records, and enabled the client to meet PRAC-EMA’s audit deadline with no missed cases.