Pharmacovigilance
We monitor drug safety during trials and after approval, tracking adverse events and making sure patients are protected.
Overview
Pharmacovigilance is about catching safety signals before they become serious problems. We set up safety databases, process adverse event reports from sites, code events using MedDRA, and prepare expedited reports for serious events. Our safety physicians review all events and make decisions about causality and expectedness.
What We Do
Setting up safety databases and standard operating procedures for event reporting
Processing and coding adverse events using MedDRA terminology
Preparing expedited safety reports for serious adverse events within regulatory timelines
Conducting signal detection analyses and preparing periodic safety update reports
Managing safety review committees and preparing safety sections for regulatory submissions
Why Work With Us
Our safety team includes board-certified physicians with pharmacovigilance training
We use validated safety databases that integrate with clinical trial systems
24/7 coverage for serious adverse event reporting to meet regulatory deadlines
Ready to Get Started?
Let's discuss how we can support your pharmacovigilance needs.