NovaVigil is Pivot Path’s AI-native pharmacovigilance platform designed to help life sciences organizations manage increasing safety workloads with greater efficiency, accuracy, and compliance. The platform automates key pharmacovigilance processes, including literature monitoring, case intake, and signal detection, while ensuring that every safety-relevant decision remains under qualified human review. By combining intelligent automation with a human-in-the-loop approach, NovaVigil reduces the burden of repetitive tasks and allows safety professionals to focus on clinical assessment, risk evaluation, and regulatory decision-making.
NovaVigil automatically screens literature sources, identifies potential adverse event cases, removes duplicates, classifies reports, and prepares coded cases for review. It also streamlines ICSR intake by capturing reports from multiple sources, extracting relevant data, coding using MedDRA, and supporting ICH E2B (R3) submissions. Advanced signal detection capabilities help identify emerging safety trends through qualitative and quantitative analysis, enabling proactive pharmacovigilance activities. Built on a validated, inspection-ready framework, the platform aligns with recognized standards including 21 CFR Part 11, EU Annex 11, CIOMS, EU AI Act, and GAMP 5. Every action is fully logged and traceable through comprehensive audit trails, supporting regulatory compliance and inspection readiness. Organizations using NovaVigil have achieved faster review times, reduced operational overhead, and greater scalability without increasing headcount, making it an effective solution for modern pharmacovigilance operations.
