Genelife’s Medical Safety department offers, preparation, reviGenelife Clinical Research CROew, approval and reporting of all SAEs reported along with tailored risk-management strategies across all stages of Product Development consistent with the requirements of applicable regulatory bodies.

  • AE and SAE logging, tracking, coding as per MeDRA/WHOdrug
  • Safety/Medical monitoring
  • Medical review of data listings
  • Review of medical coding data
  • Preparation of CTD Module II
  • Individual case safety reports
  • Expedited reporting of SAEs
  • Periodic safety updates
  • Safety analysis and benefit-risk evaluation
  • Clinical safety reports

It provides coordination of clinical and post-marketing safety data collection, processing, and reporting.