Putting Patient Health First

We Will ACCOMPLISH IT.

With the implementation of more multicenter, multinational studies, compliance with both global and local regulatory requirements has become increasingly complex. At Clinipace, our dedicated, medically qualified team helps you comply by providing tailored, pharmacovigilance and safety solutions. We have more than 50 years combined experience managing adverse events and the submission of expedited and periodic reports across a product’s life cycle.

Services

  • Safety database services
  • Development of a trial or program-specific safety management plan
  • Preparation and update of risk management plans
  • Serious adverse event (SAE)/adverse event (AE)
  • Collection, documentation, querying and follow-up within required time frames
  • Medical review and assessment of SAEs
  • Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug Dictionary coding
  • Data safety monitoring board (DSMB) – member selection, meeting support and coordination
  • Data reconciliation of safety and clinical trials databases
  • Writing of SAE/AE narratives
  • SAE/AE training for investigators and monitors
  • Expedited safety reporting
  • Periodic safety reporting
  • Signal detection and analysis
  • Literature monitoring