PHARMACOVIGILANCE

Patient safety is paramount in each and every clinical trial. Our global pharmacovigilance and device safety team is staffed by highly qualified scientists and healthcare professionals who are dedicated to providing high quality and timely safety support through all phases of drug development.

Our services are designed to maintain stringent patient safety measures for each trial we manage. We know that patient safety is an important aspect of any clinical trial, and we are committed to providing the most comprehensive safety support possible.

  • Clinical trial pharmacovigilance
  • Post- Marketing surveillance
  • Device safety
  • Expedited and periodic reporting
  • SAE / AE Case Handling, Processing & Management
  • Call Centre support
  • AE and SAE logging, tracking, coding and case processing
  • MedDRA and WHO-DD coding 2.8.2 Medical Analysis
  • AE and SAE evaluations & narrative writing
  • Physician medical review
  • Regulatory Reporting

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