The present disclosure relates to a monitoring device and a method of monitoring drug adherence in a clinical trial. In one embodiment, the monitoring device determines that an authenticated user has consumed the medication comprising the drug and further determines that the authenticated user who has consumed the drug is associated with the corresponding monitoring device. Furthermore, the monitoring device determines that the drug has successfully passed through gastrointestinal (GI) tract of the authenticated user based on analysis of biometric signatures of the GI tract. Based on the determination of valid proximity and successful passing of the medication within the GI tract of the authenticated user, the monitoring device reports that the drug adherence by the user is successful. Thus, the disclosed method and the monitoring device determine that only authenticated user has consumed the medication and not just if the medication has been taken by any person.
展开▼
