Abstract: A method for calculating a subject's state or condition comprises integrating data that are captured from multiple sources, storing the integrated data in a first database, calculating time intervals in which to collect an optimal amount of data to predict the subject state, developing a predictive model using a recorded diary or electronic data capture information, testing the model against a portion of the captured data, and applying the predictive model to new data from other sources. The predictive model may determine a subject state that may be a digital bio-marker for a disease condition. A system for predicting subject state is also disclosed.

Abstract: A system for predicting subject enrollment for a study includes a time-to-first-enrollment (TTFE) model and a first-enrollment-to-last-enrollment (FELE) model for each site in the study. The TTFE model includes a Gaussian distribution with a generalized linear mixed effects model solved with maximum likelihood point estimation or with Bayesian regression, and the FELE model includes a negative binomial distribution with a generalized linear mixed effects model solved with maximum likelihood point estimation or with Bayesian regression estimation.

Abstract: A system for generating updatable structured content includes a definition processor, a template selector, and a content generator. The definition processor processes an updatable definition to produce a plurality of reusable typed-templates, each typed-template having (1) an associated type and at least one insertion point at which another typed-template may be inserted and (2) a pointer to the updatable definition. The template selector selects at least one reusable typed-template and its associated type to store in a hierarchical structure as masterdata, where the masterdata contain a pointer to the typed-template. The content generator uses the selected reusable typed-template to produce the updatable structured content according to the associated type with pointers back to the updatable definition. A change made to the updatable definition may be propagated to the structured content and to the typed-templates.

Abstract: A perspiration sensing system includes a sensor patch and a smart device. The sensor patch includes one or more perspiration sensing portions. The one or more perspiration sensing portions include an inlet having a predefined size to receive perspiration from a predefined number of sweat glands and an outlet for reducing back pressure. At least one perspiration sensing portion includes a channel having a colorimetric sensing material that changes color when exposed to perspiration. At least one perspiration sensing portion includes a colorimetric assay in a substrate that changes color when exposed to biochemical components of perspiration. The system further includes a smart device having a camera that can take a picture of the sensor patch and determine the volume, rate of perspiration, and/or biochemical components of the perspiration from the one or more perspiration sensing portions.

Abstract: Generating a synthetic longitudinal dataset includes identifying subsequence patterns in records defining event sequences for patients. Feature vectors are determined, each characterizing a corresponding one of the records, based on the subsequence patterns. The feature vectors are embedded in a lower dimension space. A seed record is iteratively selected from among the records and in each iteration: subsequence patterns are identified in a subset of the records. Instances of subsequence patterns in the seed record are replaced with instances of similar subsequence patterns identified in the subset of the records to form a modified seed record. The iterations are repeated until all of the records have been selected as the seed record. The modified seed records are combined to form the synthetic dataset.

Abstract: A method for calculating a subject's state or condition comprises integrating data that are captured from multiple sources, storing the integrated data in a first database, calculating time intervals in which to collect an optimal amount of data to predict the subject state, developing a predictive model using a recorded diary or electronic data capture information, testing the model against a portion of the captured data, and applying the predictive model to new data from other sources. The predictive model may determine a subject state that may be a digital bio-marker for a disease condition. A system for predicting subject state is also disclosed.

Abstract: A method for generating a synthetic dataset from an original dataset includes encoding categorical features of the original dataset, embedding the encoded dataset in a low-dimensional space, selecting a seed record from the embedded dataset, identifying a plurality of nearest neighbor records to the seed record, generating a new record by randomly selecting features from the plurality of nearest neighbor records, and concatenating the new record into the synthetic dataset. For a synthetic dataset that contains N records, which may be the same as or different from the number of records in the original dataset, the selecting, identifying, generating, and concatenating operations operate a total of N times on the records in the embedded dataset.

Abstract: A system for predicting subject enrollment for a study includes a time-to-first-enrollment (TTFE) model and a first-enrollment-to-last-enrollment (FELE) model for each site in the study. The TTFE model includes a Gaussian distribution with a generalized linear mixed effects model solved with maximum likelihood point estimation or with Bayesian regression, and the FELE model includes a negative binomial distribution with a generalized linear mixed effects model solved with maximum likelihood point estimation or with Bayesian regression estimation.

Abstract: An apparatus for performing a remote test of range of motion of a person operating a user device includes a transceiver, a processor, and a display. The transceiver is configured to transmit a link to the user device and to receive motion data from the user device. The processor is configured to calculate in real time, based on the motion data, the position of the user device to enable real-time display to a test provider of the performance of the test and to determine in real time the quality of the test. The display is configured to show in real time a continuous indication of the performance of the test and quality results of the test. A method for performing a remote test of range of motion of a person operating a user device is also described and claimed.

Abstract: A perspiration sensing system includes a sensor patch and a smart device. The sensor patch includes one or more perspiration sensing portions. The one or more perspiration sensing portions include an inlet having a predefined size to receive perspiration from a predefined number of sweat glands and an outlet for reducing back pressure. At least one perspiration sensing portion includes a channel having a colorimetric sensing material that changes color when exposed to perspiration. At least one perspiration sensing portion includes a colorimetric assay in a substrate that changes color when exposed to biochemical components of perspiration. The system further includes a smart device having a camera that can take a picture of the sensor patch and determine the volume, rate of perspiration, and/or biochemical components of the perspiration from the one or more perspiration sensing portions.

Abstract: Apparatus, systems, and methods for monitoring head acceleration and/or forces acting thereon are disclosed. A device for monitoring an acceleration or a force acting on the head of a user includes a flexible article adapted to be worn on the head of the user; and a monitoring assembly coupled to the flexible article. The monitoring assembly includes a sensor for measuring a force on the head and transmitting data relating to the force, the sensor disposed proximate to the head, a processor adapted to receive the force data from the sensor, and a flexible strip operatively connecting the sensor and the processor.

Abstract: Methods and systems of storing and managing regulated content items on a non-regulated storage platform are provided. A representation of a regulated content item representing content of the regulated content item is created. The content of the regulated content item is subject to one or more regulations and the regulated content item is stored on the non-regulated storage platform. The representation of the regulated content item is provided to the non-regulated storage platform for storage. The representation of the regulated content item is configured to be accessible on the non-regulated storage platform. A request to access the regulated content item using the representation of the regulated content item is received. The regulated content item is retrieved from the non-regulated storage platform in response to the received request.

Abstract: An apparatus for automatically mapping a verbatim narrative to a term in a medical terminology dictionary includes a natural language processor and a comparator. The natural language processor processes terms from the medical terminology dictionary and from a medical coding decision database to generate a processed database that also includes the original terms from the medical terminology dictionary and the medical coding decision database. The natural language processor also processes the verbatim narrative. The comparator compares the processed verbatim narrative to the terms in the processed database and determines whether the processed verbatim narrative is an exact match to a term in the processed database. The verbatim narrative is mapped to the term in the medical terminology dictionary that corresponds to the term in the processed database that is an exact match. The verbatim narratives may include adverse event narratives, concomitant medication narratives, or other types of narratives.

Abstract: An electronic device worn on a user includes one or more accelerometers. The one or more accelerometers generate acceleration information based on acceleration experienced by the electronic device. The electronic device further includes a processor and one or more associated memories, and the one or more associate memories include computer program code executable by the processor. The processor, configured by the computer program code, causes the electronic device to process the acceleration information to extract features from the acceleration information. The processor, configured by the computer program code, further causes the electronic device to process the features to determine the location of the electronic device on the user.

Abstract: A method for determining net complexity of a clinical trial includes determining procedures to be performed during the clinical trial, determining which of the procedures may be routinely performed on clinical trial subjects suffering from the disease that the drug under test is designed to treat, determining the net procedures to be performed for the clinical trial itself, and calculating a complexity score for the net procedures. An apparatus for determining net complexity of a clinical trial is also described and claimed.

Abstract: A computer-based method for creating enforced, context-specific sharing of ontologically mapped, aggregated medical data includes storing at least one data field in a database as an entity type ontology, receiving context-specific rule configurations corresponding to the entity type ontology, and identifying any conflict between the received context-specific rule and any applicable rule. The context-specific rule configurations include at least one context, one data source, and one entity type ontology data field. If a conflict is identified, the method receives resolution of the conflict and stores the context-specific rule configurations in the database.

Abstract: An improvement to a graphical user interface disposed within a display includes a functional scrollbar, a magnifier disposed on the functional scrollbar to enhance the view of the functional scrollbar, and a filter for selecting attributes of data within a data file. The functional scrollbar includes two parts, one that has a plurality of portions indicative of content of the data file shown on the display and one that has a plurality of portions indicative of content of the data file not shown on the display. The two parts of the scrollbar include portions indicative of content within the data file that matches the filter selection. A system for generating a functional scrollbar 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: A system for generating an effective test data set for testing big data applications includes a data collector, a data analyzer, an input domain modeler, a self-adaptive input domain modeler, and a test data set generator. The data collector collects a high volume of data from an original data set and initial constraints, the data analyzer analyzes the data and the initial constraints to generate analytical results, the input domain modeler automatically generates an input domain model based on the analytical results, the self-adaptive input domain modeler generates a self-adaptive input domain model by combining the input domain model and analytical results, and the test data set generator generates an initial test data set based on the self-adaptive input domain model. A method for generating an effective test data set for testing big data applications is also described.

Abstract: A method for automating the submission of issue reports includes automatically capturing information and images related to a software user, receiving a request from the user involving an issue experienced by the user, evaluating the request and the user information and images, generating a unique identifier that matches a response received by the user when making the request to associated server log information, generating an issue report based on the user information and images, server log information, and the generated unique identifier, and generating a ticket associated with the issue report that may be communicated to an external system. The user request information and images, server log information, and unique identifier may be stored in a database or data repository. The user information and images and server log information may be automatically encrypted. A system for automating the submission of issue reports is also described.