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

Claim 0:
1. A system for managing a clinical trial of patients, the system comprising:
a memory; and
a processor coupled to the memory, wherein the processor is configured to execute a set of one or more instructions stored in the memory to:
obtain consent data a patient registered for the clinical trial, wherein the patient is associated with a clinical trial site;
authenticate the consent data by receiving a unique authentication code from a device associated with the patient;

obtain patient data comprising clinical data and non-clinical data, wherein the patient data is obtained by:
determining offline status:

assign a timestamp and a geographical location, while offline, to the patient data;
configure the device to encrypt the patient data using a data encryption scheme;
store the encrypted patient data;
detect connectivity of the device to internet to synchronize the encrypted data; and
synchronize the encrypted patient data upon detection of the internet connectivity;
transmit 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;
assign 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
generate 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.