Quality assurance in the form of monitoring of compliance is a legal obligation on those who undertake to sponsor a clinical trial of a medication. In the case of research studies, the researcher is deemed the sponsor and is thus responsible for the study being monitored.

Karolinska Trial Alliance (KTA) has the organisation in the form of staff and processes to perform monitoring of clinical trials on assignment. We work in compliance with the applicable legislation and with the international guidelines for Good Clinical Practice.

Studies are monitored regularly, beginning before the first patient is admitted to the study and ending after all the data has been processed and the study can be concluded.

Contact us to talk about your monitoring requirements.