DrugCard

PvEdge is a cloud-ready pharmacovigilance software designed to provide end-to-end compliant safety solutions for drugs, devices, vaccines, and combination products. It offers a comprehensive safety database that manages pharmacovigilance intake, case processing, submissions, AI & analytics, and safety signals all in one platform. The system adheres to existing and upcoming regulations, such as 21 CFR Part 11, ANNEX 11, GxP, and GDPR, ensuring global compliance. PvEdge utilizes advanced automation powered by AI and machine learning algorithms to enhance efficiency in drug safety database management. Key features include automated literature monitoring, ICSR submissions, smart triage, automated signal detection, and document automation. The platform also provides a controlled document management system for creating, managing, and publishing pharmacovigilance documents, as well as a risk-based enterprise quality management system to implement quality processes and training records.

Drug Safety Triager is Clarivate's next-generation pharmacovigilance software designed to assist life sciences organizations in meeting regulatory requirements. This GxP-validated, compliant, and audit-ready system manages and streamlines the literature review workflow, enabling pharmacovigilance experts to focus on patient safety by simplifying literature review processes. The platform is fully validated and compliant with the reporting requirements of global safety regulatory agencies such as the FDA and EMA. Each implementation of the Drug Safety Triager is delivered with a validation package. The validation process and associated documentation align with the pharmaceutical industry and health authority regulations. All literature references undergo a systematic review process that automatically captures all users’ actions and adds a permanent, non-editable audit trail to the record.