Implementing central statistical monitoring (CSM) in a risk-based monitoring model
In this case study, one biopharmaceutical company transitioned its clinical study portfolio to a risk-based monitoring model and sought expert guidance to implement central statistical monitoring (CSM) in support of this new approach. Identifying biostatistics resources in the clinical research industry is relatively easy, but it was imperative for this company to find the right expert to create complex statistical algorithms that would detect data outliers and anomalies across multi-site clinical trial conduct and many different sources of patient data.