This website uses cookies to provide you with a better user experience. By continuing to browse, you consent to accept our cookie policy and the installation of cookies. For more information, click on the following link.


Agree

OC vigilance

español | english

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