The software solution EarlyBird targets data anomalies on the early stages of the clinical trials and increases the data quality. High clinical data quality reduces monitoring costs, secures the FDA/EMA approval with higher resolution of the clinical effect.
At Cyntegrity we're developing a system for risk-based monitoring (RBM) of clinical trials. Even though one could argue that risk-based processes are under-represented in crucial areas of a clinical trial, the idea in general of course is not new. Risk-based approaches are well established in [...]