Ennov PV-Works is a comprehensive pharmacovigilance database that offers an efficient, compliant, and easy-to-use solution for managing patient safety data. It’s a flexible system that can manage adverse events from clinical trials, spontaneous events, medical inquiries, and product quality complaints for various medical products. Ennov PV-Works offers comprehensive data entry and reporting functions, including MedDRA coding, electronic reporting, and aggregate listing outputs. The workflow functionality ensures SOP compliance and adherence to regulatory requirements such as FDA 21 CFR Part 11, with a full audit trail. Ennov PV-Works is a process-driven system with a purpose-built workflow engine, comprehensive safety functionality, and powerful querying capabilities. It offers a fully compliant electronic submission of adverse event reports in line with ICH E2B standards and is easily integrated with standard AS2 gateway software. With Ennov PV-Works, companies can manage pharmacovigilance processes efficiently and cost-effectively.
PV-Works Human
Ensure patient safety with Ennov PV-Works, the comprehensive pharmacovigilance software that streamlines adverse event management, reporting.