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.
Electronic Data capturing is developing already for more than 30 years and penetrating the clinical research more and more. Already more than half of all clinical trials are conducted purely electronically, although the process is not yet complete. Recently did the FDA underlined its wish [...]
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 [...]