This requirement is an enhanced concept and requires a change in the mindset for the implementation of updated and new processes when conducting clinical studies. The responsibility for these processes always lies with the sponsor, irrespective if the task itself is delegated to an outside vendor. Therefore, we encourage all of our current and prospective partner sponsors to attend this timely seminar.
Join our webinar and meet Gunnar Danielsson, Senior regulatory adviser at LINK Medical, and former GCP Inspector talk about this subject. At this seminar you will learn:
- Practical implementation of Risk-Based Monitoring and how RBQM can support clinical trials during a pandemic situation
- How to change the mindset for the implementation of updated processes
- Understand what authorities expect in regards to RBQM