Abstract: A computer-implemented federated studies system and method are disclosed. The system includes: a predefined common data model associated with a study; a set of sites of origin, each associated with a set of input devices for acquiring study data from subjects and a study data device. Each study data device includes: a database for storing study data derived from input devices; a data model translator for translating study data to a common data model format; a common model database for storing, in the data model, individual participant values derived from study data; a study compute module for determining site aggregate values from individual participant values; and an aggregate database for storing site aggregate values. A site of analysis is associated with a study analysis device that includes: an analysis compute module for processing site aggregate values received from sites of origin; and a reporting module for generating study reports.