Project Description

Klinisches Monitoring für das Einhalten regulatorischer Anforderungen und gute klinische Praxis GCP

We provide clinical monitoring services that ensure your study complies with all regulatory requirements – and adheres to Good Clinical Practice at every stage. We interpret monitoring not only as the critical scrutiny and verification of data to ensure their integrity. On site our monitors (CRAs) are more than our eyes and ears – they represent GKM and its sponsors. While performing monitoring tasks, they also provide diplomatic yet definitive guidance to investigators and site personnel. This challenging monitoring task demands a truly expert touch.

We only send local, native speakers to the trial sites in each country for monitoring. Every single clinical monitor on our books has a minimum of two years’ professional monitoring experience, and is supervised carefully at every stage of the project.

What’s more, we enjoy long-standing and strong partnerships with our freelance CRAs who are in charge of monitoring. We take special care to provide our CRAs the best possible project-specific training – be it in terms of general monitoring requirements or project- and indication-specific training in a way that they can disseminate their knowledge to the sites they are monitoring. This winning combination of personality, expertise and experience ensures smooth study conduct.