- By implementation of RBM pilot are you sure, you are looking at all relevant risks within a trial?
- Are there other risks that could be missed?
- Does RBM add additional risks?
If we rely too much on some sort of “formula”, there can be adverse effects on the quality and patient safety.
Technology plays a critical role in effective RBM. However, monitoring and trial management team are more important.
RBM is not a “formula” to configure and forget. It demands a structured, holistic approach. Only then, it can be used as a powerful tool to increase efficiency of clinical trial management.
Cyntegrity has reach experience in design and implementation of an Integrated Risk-Based Monitoring helping to a company to go through change management and build up a full process around efficient RBM.