By Thi Nguyen
Risk-based monitoring (RBM) is heralded as the new solution to all troubles in clinical research – the exorbitant complexity, the ridiculous costs, the nerve-wracking SAEs. Sponsors and CROs are gradually adopting RBM, but many still hesitate to jump on the bandwagon.
Sometimes RBM and centralized (also called central or remote) monitoring are used interchangeably, but they shouldn’t be. RBM is an addition to a monitoring strategy, whether on-site or centralized (or both). For example, all monitoring activities can be done in person with RBM, remotely without RBM, or both physically and remotely with or without RBM. Centralized monitoring does not automatically include RBM practices, but they can complement each other.
There are no concrete instructions when it comes to RBM, and planning a successful RBM design can be challenging. Even so, we believe investing in an experienced partner to help you with RBM design is worthwhile. RBM can be an indispensable tool for your trial’s success. Following is an out of outline a criteria that could be helpful in finding the right RBM specialist.