Pharmacovigilance and medical monitoring

 SMERUD’s pharmacovigilance (PvG) unit provides services related to safety monitoring. We have trained and qualified personnel to act as Qualified Persons (QP) for PvG, and we have experienced clinical research physicians employed who will be responsible for the medical monitoring of the data.

 Prior to the inception of a study, a Safety Reporting Plan is agreed, which clearly define the responsibilities with respect to safety reporting. Processing e.g. of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), expectedness of adverse drug reactions, exclusion of SAEs as defined in the protocol, and Early Terminations on grounds of safety must be covered in this document.

 We can support our clients in registering their QPs or responsible persons for PvG in the Eudravigilance system so that EVWEB can be used for expedited safety reporting.

Pharmacovigilance services include:

  • Eudravigilance registration
  • Safety Reporting Document
  • Medical review of adverse events in clinical trials
  • SAE processing / SUSAR Reporting
  • Adverse Event reporting
  • Annual Safety Reports
  • Post-marketing safety monitoring / database / PSURs / Eudravigilance
  • Data classification according to MedDRA
  • MedDRA training