Drug Safety & Pharmacovigilance

Pkinetix provides the following drug safety and pharmacovigilance services:

  • Individual case safety review (ICSR).
  • Aggregate Reporting (PSURs, PADERs and DSURs).
  • Risk Management Plans (RMP).
  • Risk Evaluation & Mitigation Strategies (REMS).
  • Signal Detection & Management.
  • Literature Search.
  • Clinical Trial Safety Management.