Pharmacovigilance is vital when conducting clinical trials. Our approach includes:

  • Serious Adverse Event (SAE) reporting and follow-up
  • Safety system/database design
  • Online coding (MedDRA, WHO-ART) of adverse event information
  • Preparation and submission of global safety reports
  • Preparation of IND safety reports and alert letters
  • Medical monitoring
Rigorous safety investigation has helped many new drugs enter the marketplace. We provide:

  • Safety data management, processing, and reporting
  • Data Safety Monitoring Board establishment and management
  • Regulatory affairs expertise