Putting Patient Safety First

We are implementing more complex multicenter, multinational studies, with both global and local regulatory requirements furthering the need for absolute compliance. At Clinipace, our dedicated medical and pharmacovigilance team helps you manage adverse events and the submission of expedited and periodic reports across a product’s life cycle and across the globe.

Services

  • Safety database services
  • Medical data review
  • Development of a trial or program-specific safety management plan
  • Expedited safety reporting
  • Signal detection and analysis
  • Serious adverse event (SAE)/adverse event (AE) case processing
  • Writing of SAE/AE narratives
  • Data safety monitoring board (DSMB) — member selection, meeting support, and coordination
  • Preparation and update of risk management plans
  • Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug Dictionary coding
  • Data reconciliation of safety and clinical trials databases
  • SAE/AE training for investigators and monitors
  • Literature review