Patent ID: 11967402
Assignee: CLINIOPS INC.
Field: Medical technology (Instruments)
Classification: CPC G | IPC G

Claim 14:
15. A system for managing a clinical trial of patients, the method comprising:
obtaining consent data a patient registered for the clinical trial, wherein the patient is associated with a clinical trial site;
authenticating the consent data by receiving a unique authentication code from a device associated with the patient;, obtaining patient data comprising clinical data and non-clinical data, wherein the patient data is obtained by:
determining offline status;, assigning a timestamp and a geographical location, while offline, to the patient data;, configuring the device to encrypt the patient data using a data encryption scheme;, storing the encrypted patient data;, detecting connectivity of the device to internet to synchronize the encrypted data; and, synchronizing the encrypted patient data upon detection of the internet connectivity;, transmitting notification automatically to the patient and the clinical trial site for recording the patient data based on timelines in a compliance calendar for the patient, wherein the compliance calendar comprises date, time, and a type of clinical data type and non-clinical data corresponding to a stage of the clinical trial;
randomly group patient based on the clinical data and the non-clinical data for performing blinded study in the clinical trial using one of a permuted blocked stratification and a minimization technique for randomly grouping the patient;
assigning a unique Quick Response (QR) code to the patient in the group for tracking completeness of activities assigned to the patient during the clinical trial, wherein the activities are assigned based on the obtained patient data;, automatically manage one or more of timelines, progress, compliance, and data associated with the stage of the clinical trial, based on the compliance calendar; and, generating in real time an analysis report indicating a change in a level of one or more parameters associated with the clinical trial site, the clinical data, and the non-clinical data of the patient over a period of time of the clinical trial for performing the blinded study, wherein the one or more parameters include one or more symptoms, compliance, and number of patients dropping out.