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