PV360™: A Real-Time Medical Assessment Platform for Pharmacovigilance (PV)
Executive Summary
PV360™, also known as “MedSafety 360”, is an innovative, real-time medical assessment platform purpose-built for pharmacovigilance (PV), covering safety data from both clinical trials and post-marketing reporting. PV360 connects billions of data points across millions of records in real time, empowering safety teams to navigate seamlessly from the big pictures to the granular details, accelerating medical decision-making and risk mitigation, and supporting regulatory submissions.
Product Overview
PV360™ is designed to transform how medical assessment and safety analysis are conducted for pharmacovigilance data, offering:
Real-time medical insights from industry-leading safety databases (e.g., Argus, ArisG, RxLogix) and CDISC clinical trial data (Adverse Event, Exposure, Lab, etc.), with a proven track record in guiding medical decision making and responding to health authority inquiries.
From the big picture to granular details connecting aggregate analytics (metrics, trending, disproportionality), case series, and individual case review, capturing critical details such as product hierarchy, listedness, medical history, concomitant medications, causality, and narratives.
User-centric design with intuitive navigation and customized features, such as SUSAR, Hepatocellular Injuries, Hy’s Law and custom MedDRA list.
Advanced add-ons such as Medical Assessment Integration, Machine Learning for Causality, and Narrative Text Mining.
