Rhythm by Womb WatchAI® is a Digital Health Technology layer that runs alongside your existing EDC to support your candidate's path to FDA approval and the US market. Architected to 21 CFR Part 11 requirements, it captures immutable, timestamped, participant-reported pain across the body and across the menstrual cycle, without changing your protocol or your endpoints: differentiated evidence for your FDA discussions, written while the trial runs, while capturing the analgesic use, clinic visits, and surgical outcomes US payers require for reimbursement.
The Bio-Intent Orchestration System™ is the operating infrastructure for decisions on health data, offered as a service. It links the records an institution already holds with the continuous patient record only we originate, and delivers Health Mapping™, complex link analysis, decision support, and data analytics for payers, providers, and pharmaceutical sponsors. We deploy it with your teams, on your questions; enterprise terms available on request.