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OC vigilance

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Pharmacovigilance of clinical trials

OC Vigilance offers the following services in this area:

  • management of serious adverse events (SAEs)
  • Submission of unexpected serious adverse reactions (SUSAR) to the competent authorities
  • Coding of medical histories and adverse events with MedDRA dictionary (Medical dictionary for Regulatory Activities)
  • Coding of concomitant medication according to ATC Index (Anatomical Therapeutic chemical classification system) published by OMS
  • Periodic reconciliations between different databases of clinical trials
  • Elaboration of annual safety reports from clinical trials (DSUR: Development Safety Update Report)
  • Protocol Review
  • Inclusion of information on investigational drugs in XEVMPD (Extended Eudravigilance Medical Product Dictionary)
  • Audits of clinical trials