Abstract: A system for developing a model to automatically determine the probability that a serious adverse event occurred during a clinical trial includes a clinical data standardizer, a data processor, and a model developer. The clinical data standardizer receives clinical trial data and standardizes the clinical trial data and form and field names across clinical trials. The data processor generates standardized adverse event terms from the standardized data and form and field names. The model developer merges the standardized adverse event terms and other adverse event data, demographic information, and trial features and develops a serious adverse event (SAE) machine learning model.