Global Pharmacovigilance and Signal Detection
Safeguarding subject safety and proactive risk management are fundamental to the success of a clinical trial. A major hurdle in pharmacovigilance is to be able to discern between AEs that are related to the investigational medicinal product versus those unrelated. We have developed a proprietary tool to standardize and facilitate this process and our sophisticated signal detection capabilities help you differentiate safety events between “noise” and potential trends/signal during your development program.
Our PV services include:
Safety Management Plan & Risk Management Plan generation
Global literature surveillance
Case processing including ICSR & aggregate safety report preparation and submission
MedDRA coding
Proprietary Causality Assessment Tool
Signal detection and trends management
QPPV services
Medical Monitoring and Safety Physician services
Global regulatory submissions
Annual regulatory reporting (DSUR, PSUR, PBRER)
Talk to us about all of your pre-market and post-market PV requirements.