Claims:We Claim:
1. A method of monitoring drug adherence in a clinical trial, said method comprising:
receiving, by a monitoring device, one or more first signals indicative of physiological information associated with a user upon consuming a medication comprising the drug;
determining, by the monitoring device, authenticity of the user consuming the medication based on comparison of the physiological information associated with the one or more first signals with previously stored physiological information associated with a plurality of concerned users;
detecting, by the monitoring device, valid proximity of the monitoring device to the medication consumed by the authenticated user based on signal strength associated with one or more second signals received from the medication;
determining, by the monitoring device, successful passing of the medication within gastrointestinal (GI) tract of the user based on one or more biometric signatures generated by the medication during the passing within the GI tract of the authenticated user; and
reporting, by the monitoring device, successful drug adherence of the user based on determination of valid proximity of the monitoring device with the medication and successful passing of the medication within the GI tract of the authenticated user.

2. The method as claimed in claim 1, wherein receiving the one or more first signals comprises receiving the one or more first signals from one or more first physiological sensors coupled with the monitoring device.

3. The method as claimed in claim 1, wherein detecting valid proximity of the monitoring device to the medication comprising the steps of:
receiving one or more second signals from one or more second sensors configured in the medication;
comparing the RSSI value of each of the one or more second signals with a predetermined threshold value; and
determining that the monitoring device is located in a valid proximity to the medication consumed by the authenticated user, based on the comparing.

4. The method as claimed in claim 1, wherein determining successful passing of the medication within the GI tract of the authenticated user comprising the steps of:
deriving at least acceleration, pH and temperature information of the medication from the one or more second signals during the passing of the medication within the (GI) tract of the authenticated user;
determining one or more features including at least a long term feature, a short term feature and a peristaltic feature associated with the GI tract, based on the derived information;
generating the one or more biometric signatures associated with the GI tract based on the determined features;
determining probability of passing of the medication within the GI tract of the authenticated user based on the one or more biometric signatures;
comparing the probability of passing with a predetermined threshold probability; and
determining successful passing of the medication within the GI tract of the authenticated user based on the comparing.

5. The method as claimed in claim 1, further comprising activation of the medication by triggering an activation switch coupled with the medication before consumption of the medication by the user.

6. The method as claimed in claim 1, further comprising:
creating one or more user profiles for the one or more concerned users;
obtaining one or more test physiological signals from the monitoring device indicative of physiological information associated with the one or more concerned users upon consumption of a dummy medication;
generating one or more test biometric signatures associated with the GI tract of the one or more users;
determining a test probability value indicating one of passing and non-passing of the dummy medication within the GI tract of the one or more concerned users; and
updating the one or more user profiles with the corresponding physiological information and test probability value corresponding to the one or more concerned users.

7. A monitoring device for monitoring drug adherence in a clinical trial, said system comprising:
at least one first physiological sensor capable of receiving one or more first signals indicative of physiological information associated with a user;
a processor coupled with the at least one first physiological sensor; and
a memory disposed in communication with the processor for storing processor-executable instructions, the instructions comprising instructions to:
receive the one or more first signals upon consuming a medication comprising the drug;
determine authenticity of the user consuming the medication based on comparison of the physiological information, associated with the one or more first signals, with previously stored physiological information associated with a plurality of concerned users;
detect valid proximity of the monitoring device to the medication consumed by the authenticated user based on signal strengthassociated with one or more second signals received from the medication;
determine successful passing of the medication within gastrointestinal (GI) tract of the user based on one or more biometric signatures generated by the medication during the passing within the GI tract of the authenticated user; and
report successful drug adherence of the user based on determination of valid proximity of the monitoring device with the medication and successful passing of the medication within the GI tract of the authenticated user.

8. The system as claimed in claim 7, wherein the processor is configured to detect valid proximity of the monitoring device to the medication by performing the steps of:
receiving one or more second signals from the one or more second sensors configured in the medication;
comparing the RSSI value of each of the one or more second signals with a predetermined threshold value; and
determining that the monitoring device is located in a valid proximity to the medication consumed by the authenticated user, based on the comparing.

9. The system as claimed in claim 7, wherein the processor is configured to determine successful passing of the medication within the GI tract of the authenticated user by performing the steps of:
deriving at least acceleration, pH and temperature information of the medication from the one or more second signals during the passing of the medication within the gastrointestinal (GI) tract of the authenticated user;
determining one or more features including at least a long term feature, a short term feature and a peristaltic feature associated with the GI tract, based on the derived information;
generating the one or more biometric signatures associated with the GI tract based on the determined features;
determining probability of passing of the medication within the GI tract of the authenticated user based on the one or more biometric signatures;
comparing the probability of passing with a predetermined threshold probability; and
determining successful passing of the medication within the GI tract of the authenticated user based on the comparing.

10. The system as claimed in claim 7, wherein the processor is further configured to activate the medication by triggering an activation switch coupled with the medication before consumption of the medication by the user.

11. The system as claimed in claim 7, the processor is further configured to:
create one or more user profiles for the one or more concerned users;
obtain one or more test signals from the monitoring device indicative of physiological information associated with the one or more concerned users upon consumption of a dummy medication;
generate one or more test biometric signatures associated with the GI tract of the one or more users;
determine a test probability value indicating one of passing and non-passing of the dummy medication within the GI tract of the one or more concerned users; and
update the one or more user profiles with the corresponding physiological information and test probability value corresponding to the one or more concerned users.

12. The system as claimed in claim 7, wherein the monitoring device is configured as one of a wearable device, a hand held device and an embedded device.
13. A non-transitory computer readable medium including instructions stored thereon that when processed by at least one processor cause a system to perform acts of:
receiving one or more first signals indicative of physiological information associated with a user upon consuming a medication comprising the drug from one or more first physiological sensors;
determining authenticity of the user consuming the medication based on comparison of the physiological information associated with the one or more first signals with previously stored physiological information associated with a plurality of concerned users;
detecting valid proximity of a monitoring device to the medication consumed by the authenticated user based on signal strength associated with one or more second signals received from the medication;
determining successful passing of the medication within the GI tract of the user based on one or more biometric signatures generated by the medication during the passing within the GI tract of the authenticated user; and
reporting successful drug adherence of the user based on determination of valid proximity of the monitoring device with the medication and successful passing of the medication within the GI tract of the authenticated user.

Dated this 13th day of November, 2015
M.S. DEVI
OF K&S PARTNERS
AGENT FOR THE APPLICANT
, Description:FIELD OF THE DISCLOSURE
The present subject matter is related, in general to monitoring system, and more particularly, but not exclusively to a monitoring device and a method of monitoring drug adherence in a clinical trial.