Our Product Safety Officers provide comprehensive case management, including collection, triage, and assessment from various sources, data entry into safety databases, causality assessment, narrative writing, medical review, and the preparation and timely electronic submission to regulatory authorities and partners, with follow-up tracking and documentation.

One of the many solutions how the GCPS team performs signal detection is by using a production-ready, in-house developed and validated application, ClinSight. It is designed for the medical monitoring of patient safety and data integrity throughout clinical trials. It provides multiple ways to keep track of changes in clinical trial data and includes interactive visualizations that offer an efficient patient overview —something not typically possible with standard Electronic Data Capture (EDC) systems.

Our Product Vigilance Team  delivers tailored Safety Management Plans (SMPs) designed to cover the unique needs of your clinical study. Whether it’s EMA registration, XEVMPD entries, or EVWEB and Gateway reporting, we ensure every detail is handled with precision. Our Product Safety Officers ensure fulfilment of global medical device vigilance and pharmacovigilance obligations, which are essential for patient safety and regulatory compliance.