Pharmacovigilance in clinical studies refers to processes that provide ongoing monitoring of the safety of study volunteers during the course of a clinical study involving drugs.
Amongst other things, pharmacovigilance includes the timely recording and assessment of incidents and adverse events. If these events affect the risk-benefit ratio of the study, Ethics Committees and authorities must be notified.
If required, KKS can take over pharmacovigilance processes, thereby fulfilling the sponsor's obligations.
Our pharmacovigilance service offering includes:
- SAE management
- SAE 2nd assessment and reporting to sponsors
- SUSAR reporting to authorities and Ethics Committees
- Annual safety reports (Development Safety Update Reports (DSUR)