Case Study: Leading PV Tech and Services Solution Company achieves rapid reconciliation of 277K legacy safety records in under 2 months with IQVIA

Leading PV Tech and Services Solution Company - Customer Case Study

Leading PV Tech and Services Solution Company faced a time-critical compliance challenge: legacy REMS records for two products, held by a third-party, contained interactions from ~2,500 patients in multiple formats and needed rapid reconciliation after a documentation update to ensure no missed safety events and to meet an upcoming periodic report. IQVIA — leveraging its Lifecycle Safety Services (LCS) and Vigilance Detect technology — was engaged to perform the review and support remediation.

IQVIA deployed an instance of Vigilance Detect with a GxP-compliant workflow and LCS quickly onboarded 40 global PV specialists to validate technology outputs and update the client’s safety database. The combined tech-and-services approach was in production in <4 weeks and the project completed in <2 months: 277K records reviewed, 15K records auto-filtered out, OCR enabled review of >15K PDFs, and 54% of flagged items were confirmed as safety events; the engagement also halved resourcing needs compared with a manual-only approach (80 vs 40 FTE).