Safety information management

With elevating importance of safety information management, our staff with rich knowledge and expertise will support you through the increasingly complicated work in pharmacovigilance.

List of Services

  • Individual Case Safety Report (ICSR) processing (domestic and foreign cases)
  • Database entry
  • Preparation of e-Files
    (ICSR File, Content J File, Report Form for PMDA, CIOMS, Individual reporting format of each Sponsor, etc.)
  • Primary Assessment (expectedness)
  • Translation
  • Drafting re-investigation (query) instructions
  • Drafting materials for safety evaluation meeting

Inquiries about our services

Click here if you are interested in outsourcing your operations to us.