Patent ID: 8515774

Claim:
A method of determining and reporting clinical study compliance by an analytical device including a processor, a memory and a networking interface, the method comprising: accessing, by the analytical device, standard operating procedures associated with a clinical study from a first database; transforming, by the analytical device, the standard operating procedures into quality-related rules based on a clinical workflow associated with the clinical study; storing the quality-related rules in a second database; accessing, by the analytical device, first clinical data associated with patients associated with the clinical study from a third database, the first clinical data including measured criteria; determining, by the analytical device, non-measured criteria from the measured criteria and at least one weighting factor based on the measured criteria and the non-measured criteria; determining, by the analytical device, weighted criteria based on the at least one weighting factor, the measured criteria, and the non-measured criteria; accessing, by the analytical device, second clinical data from at least one of a clinical workflow management system and a hospital information system; evaluating, by the analytical device, the first clinical data and the second clinical data against the quality related rules; determining, by the analytical device, a measure of compliance based on the weighted criteria and the evaluation; using, by the analytical device, the determined measure of compliance for calculating a ranking of compliance for a plurality of clinical trial sites; and reporting, by the analytical device, the measure of compliance to at least one of a sponsor of the clinical study and a contract research organization managing the clinical study.