Risk-based monitoring

For years, the pharmaceutical industry has been using 100% source document verification (SDV) methods and on-site monitoring. This basically means that persons from the pharmaceutical company or CRO, go to the clinical research site and review every document, from the patients’ files to the regulatory binders. This has worked, but nowadays the protocols are getting more and more complex, and a more efficient method of review is needed without compromising the quality of the monitoring activities.

In recent years, risk-based monitoring (RBM) is being used as a more convenient methodology for the quality review the protocols need. RBM takes advantage of the technology we have today so the information can be reviewed “off-site” or what is also called, centralized monitoring. This allows monitors or managers from the pharmaceutical companies to verify information on the systems, such as the eCRF, and review the protocol compliance. This can be done remotely without having to visit the sites, saving time and money in travel.

Since RBM is focused on study-specific critical data and processes, it allows the monitors to detect issues in critical points of the protocol, such as adverse events, investigational product dosing, common deviations, etc. This is great for preventing errors from occurring and it is a more direct review of the information. On the moment the monitor detects some values out of range, he or she contact the site in order to see what is going on, instead of having to wait for the on-site verification.

At Althian, we have participated in protocols that use this methodology for monitoring and reviewing information and we can say that it is working very well. We are glad to be part of the newest advances in clinical research. Contact us for more information about our experience with RBM and we’ll be happy to help!