One of KKS's main offerings is the monitoring of clinical studies. Monitoring refers to the process of Quality Control in clinical trials and is a statutory requirement. It involves checking the procedure in terms of ICH-GCP (Good Clinical Practice) and the trial protocol. Depending upon the monitoring level that has been agreed, correct documentation in the trial forms (Source Data Verification), essential documents and use and storage of the study medication are checked.
In performing this service, KKS acts independently of the clinical organisational units of the Medical University of Vienna, in order to avoid any conflict of interest.
KKS offers monitoring as a stand-alone service or in combination with project management. External commercial companies are also able to use this KKS service.
We will be happy to provide you with a non-binding cost proposal.