PvEdge Reviews & Product Details

Sarjen's PvEdge Automation is a highly capable and globally compliant pharmacovigilance solution designed to streamline and automate critical safety processes for a wide range of products, including drugs, devices, and vaccines. It functions as a single, centralized safety database that enhances compliance and efficiency throughout the entire pharmacovigilance lifecycle. The system is built to handle a variety of functions, starting with the initial intake/triage of safety information from multiple sources, such as MICC, literature, and regulatory agencies. This multi-source inbox capability ensures all potential adverse event reports are captured effectively. Once the data is received, the system automates complex case processing tasks. It includes features like MedDRA auto update for accurate medical coding, generation of a detailed patient narrative, and comprehensive QC checklists to maintain data integrity. The software is engineered for global regulatory compliance, supporting various submission formats like R2 XML, R3 XML, CIOMS, and Medwatch. It facilitates seamless submissions to major regulatory bodies such as the FDA, MHRA, EMA, PMDA, and TGA, often through an AS2 gateway for secure data exchange. Beyond core case management, the solution offers robust reporting capabilities, including the automated publishing of PSUR/PADER/TDC reports, and supports other essential functions like risk management plans and safety data exchange agreements. The system is also equipped with advanced analytics, using algorithms like proportional reporting ratio (PRR) and Chi-square algorithm to identify safety signals. With its AI-enabled and multi-tenant architecture, the software is cloud-ready and offers rapid implementation, presenting a strong return on investment for life sciences companies seeking to modernize their pharmacovigilance operations.