Abstract: A method includes providing one or more instructions to perform a first action associated with administration of a medication; obtaining first data representing a capture of a patient performing the first action based on the one or more instructions as output by the output device; extracting information about movements of the patient from the first data; presenting an image configured to induce an emotional response in the patient; obtaining second data representing capture of the patient performing one or more microexpressions in response to presentation of the image; obtaining additional data including one or more of demographic information of the patient, information of a disease associated with the patient, or one or more characteristics of the medication; and based on the extracted information about the movements, the one or more microexpressions, and the additional data, determining a medical outcome including a progression of the disease in the patient.

Abstract: A method includes providing one or more instructions to perform a first action associated with administration of a medication; obtaining first data representing a capture of a patient performing the first action based on the one or more instructions; extracting information about movements of the patient from the first data; presenting an image configured to induce an emotional response in the patient; obtaining second data representing capture of the patient performing one or more microexpressions within 250 milliseconds of presentation of the image; obtaining additional data including one or more of demographic information of the patient, information of a disease associated with the patient, or one or more characteristics of the medication; and based on the extracted information about the movements, the one or more microexpressions, and the additional data, determining a medical outcome including a progression of the disease in the patient.

Abstract: A method for ensuring the integrity of data includes receiving audits from an eClinical system, generating a data stream and a first audit stream, generating a first hash number by applying a hash algorithm to the first audit stream, transmitting the data stream and first audit stream to a data provider, and transmitting the first hash number to an error checker. The data provider provides to the error checker a second audit stream, and the error checker generates a second hash number based on the second audit stream and compares the first hash number to the second hash number. A system for ensuring the integrity of data is also described and claimed.

Abstract: A method and system for generating a master clinical database from disparate sources, including public databases, private databases, and data from users, correlating the received data, determining a degree of confidence in and requesting and seeking confirmation of any data matched from the correlated data. The invention may identify key time points and users from whom to seek and receive confirmation of correlated data. The invention may be utilized to create a cross-trial, cross-sponsor, clinical master database that maintains appropriate user, subject and data confidentiality and privacy and which may be utilized to facilitate study design collaboration.

Abstract: An apparatus for monitoring changes in symptoms of a patient is described. The apparatus includes a display for displaying information to a patient; a processing system configured to output to the display at least one of audio, video or both audio and video stimuli for eliciting a reaction in the patient; an audio and video capture device for capturing audio, video or both audio and video recordings of the patient performing an action as the stimuli is output by the display; a computer vision processor configured to determine from the audio, video or both audio and video recordings, one or more reactions of the patient in response to the stimuli and during a first period of time immediately after presentation of the stimuli to the patient, wherein the first period of time is less than 250 milliseconds.

Abstract: An apparatus for analyzing changes in symptoms of a patient is described.

Abstract: A system for user-initiated analysis of changes in symptoms of a patient is described. The system includes a storage device for storing data captured of a patient performing an action in response to a stimulus presented to the patient. The stimulus presented to the patient includes one or more instructions provided to the patient in accordance with monitoring of medication administration of the patient. The action performed in response to the stimulus presented to the patient includes the action of the patient performing a requested step indicative of proper medication administration and is indicative of a change in one or more symptoms associated with a disease and the overall progression of the disease, the storage device further storing one or more item selected from the group of: demographic information of the patient, disease progression information of the patient, and one or more medication characteristics of the medication subject to the medication administration monitoring process.

Abstract: A method for generating a unified database includes receiving a structured set of data, where each set is made up of records having fields, aggregating values within a first field of the records, automatically applying a set of rules to the first field values to determine correlations among the first field values, calculating a confidence level regarding a label for the first field, providing the label to the first field, storing the first field values in the first field in the unified database, and receiving more information to increase the confidence level. A system for generating a clinical database and a method for using the database are also described.

Abstract: An improved clinical trial patient burden calculating system includes a data analyzer to calculate scores and weights for patient burden components, a plurality of data calculators to calculate a respective plurality of sub patient burden indexes based on the patient burden component scores and weights, and an aggregator to calculate a procedure-level patient burden index based on aggregation of the sub patient burden indexes. An improved method for calculating clinical trial patient burden is also described and claimed.

Abstract: A method for ensuring integrity of data includes receiving data from a clinical source, assembling the data into a first data stream, generating a first hash number by applying a hashing algorithm to the first data stream, transmitting the first data stream to a data provider, and transmitting the first hash number to a data checker. The data provider provides to the data checker a second data stream and the data checker generates a second hash number based on the second data stream and compares the first hash number to the second hash number. A system for ensuring integrity of data is also described and claimed.

Abstract: A method and system for generating a master clinical database from disparate sources, including public databases, private databases, and data from users, correlating the received data, determining a degree of confidence in and requesting and seeking confirmation of any data matched from the correlated data. The invention may identify key time points and users from whom to seek and receive confirmation of correlated data. The invention may be utilized to create a cross-trial, cross-sponsor, clinical master database that maintains appropriate user, subject and data confidentiality and privacy and which may be utilized to facilitate study design collaboration.

Abstract: Disparate (heterogeneous) clinical data recording devices are assimilated into a unified clinical system that is able to function regardless of the disparate data protocols of the recording devices. The unified system is realized in some embodiments by cascading a consistent set of audits generated by the recording devices through downstream clinical components, which audits provide a permanent and indelible record. The cascaded audits may also serve as a means of instruction between the disparate components of a unified clinical system.

Abstract: A method for generating a unified database includes receiving a structured set of data, where each set is made up of records having fields, aggregating values within a first field of the records, automatically applying a set of rules to the first field values to determine correlations among the first field values, calculating a confidence level regarding a label for the first field, providing the label to the first field, storing the first field values in the first field in the unified database, and receiving more information to increase the confidence level. A system for generating a clinical database and a method for using the database are also described.

Abstract: A method for generating a unified database includes receiving a structured set of data, where each set is made up of records having fields, aggregating values within a first field of the records, automatically applying a set of rules to the first field values to determine correlations among the first field values, calculating a confidence level regarding a label for the first field, providing the label to the first field, storing the first field values in the first field in the unified database, and receiving more information to increase the confidence level. A system for generating a clinical database and a method for using the database are also described.

Abstract: A method for generating a unified database includes receiving a structured set of data, where each set is made up of records having fields, aggregating values within a first field of the records, automatically applying a set of rules to the first field values to determine correlations among the first field values, calculating a confidence level regarding a label for the first field, providing the label to the first field, storing the first field values in the first field in the unified database, and receiving more information to increase the confidence level. A system for generating a clinical database and a method for using the database are also described.