A validated web-based application that enables the collection, evaluation, monitoring, and storage of adverse events on a single platform while producing outputs in compliance with the ICH E2B(R3) standard. The platform fully meets the requirements of ICH E2B(R3): Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs) for the electronic submission of adverse event reports. Additionally, it is fully compliant with Good Pharmacovigilance Practices (GVP) standards for conducting pharmacovigilance activities in the European Union and other regions.This application offers critical features such as signal management for adverse event assessment, supporting pharmacovigilance processes reliably, efficiently, and effectively through its full compliance with global standards.