Since 2013, the USFDA has recommended risk-based monitoring (RBM) to help sponsors (pharmaceutical or biotech companies) fulfill their responsibility to monitor clinical research performance, a concept that is also being accepted by EU regulatory agencies. RBM is also widely established in the USA, EU and Asia. Many international studies are now beginning to implement RBM by identifying protocol and program risks.
In addition to its traditional monitoring services, EPSI has extended its RBM services to help clients respond to changes in monitoring approaches. EPSI's project managers work with clients, the data management team and internal divisions to identify risks and propose RBM solutions to clients.
A full range of risk based monitoring services that are your assurance of successful clinical trials.
EPSI is aware that each study requires a unique approach. Please contact us at firstname.lastname@example.org to inquire about the RMB model proposal that best suits your study design.