Customized Risk Based Monitoring Brochure

In line with recent EMEA and FDA guidance and in support of the industry movement towards remote monitoring, Chiltern has developed a robust Risk Based Monitoring (RBM) model for clinical studies based on direct experience. This strategic approach moves from a classical 100% source document review at site to a more effective targeted data monitoring model, where specific study risks and site performance are continuously assessed. Recognizing that early and ongoing integrated data review by all functions is essential to an effective RBM strategy, Chiltern has produced a customized data monitoring model that is tailored for each individual study site, concentrating resources on risk to data and patient safety.