Indivirtus

  • Receive initial and follow-up clinical trial and post-marketing cases via email and E2B (EDC, license partners, authorities)
  • Triage cases to determine priority and due date for each ICSR
  • Perform clinical trial data reconciliation
  • Provide translation services
  • Perform duplicate check(s) to manage follow-ups and duplicates received
  • Store source documents electronically in the safety database
  • Track receipt of each report and send acknowledgements to sender
  • Confirm report meets minimum criteria for entry in safety database and manage invalid reports
  • Perform reconciliation of ICSR’s received against list of cases submitted by Call center, Product Technical Complaints, Unsolicited and Solicited sources, and business partners
Our Clients: