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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.

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