Pharmacovigilance and medical monitoring

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

Before the inception of a study, a Safety Management Plan is agreed upon, which clearly defines the responsibilities concerning safety assessment and reporting. Processing of Serious Adverse Events (SAEs), including assessments of causality and expectedness, SUSAR (Suspected Unexpected Serious Adverse Reactions) reporting, exclusion of SAEs as defined in the protocol, and Early Terminations on the grounds of safety must be covered in this document.

A Medical Monitoring Plan outlines the safety overview activities to be undertaken by our medical monitors.

We can support our clients in registering their QPPV or responsible person for PV in the Eudravigilance system so that EVWEB can be used for expedited safety reporting.

Pharmacovigilance services include:

• Eudravigilance registration
• Safety Management Plan
• Medical Monitoring Plan
• Adverse Event reporting
  
• SAE processing / SUSAR Reporting
• Medical review of adverse events in clinical trials
• Data coding according to MedDRA
• Annual Safety Reports
• Literature screening