Abstract: Systems and methods for predictive clinical planning, design, and integrated execution services are provided. The system may comprise a database, a web server, an application server, and a client. The system may be used to develop a strategic map of a proposed clinical plan, wherein the clinical plan may include a draft launch label attribute, one or more strategies, and a schema; linking the clinical plan and schema to one or more trials; subsequently linking the trials to one or more objectives and measures; subsequently linking none, one, or a plurality of objectives to none, one, or a plurality of measures; identifying patient criteria and enrolling patients from one or more investigator sites located in one or more countries; and integrating the clinical plan with a clinical plan execution application.

Abstract: Systems and methods for predictive clinical planning, design, and integrated execution services are provided. The system may comprise a database, a web server, an application server, and a client. The system may be used to develop a strategic map of a proposed clinical plan, wherein the clinical plan may include a draft launch label attribute, one or more strategies, and a schema; linking the clinical plan and schema to one or more trials; subsequently linking the trials to one or more objectives and measures; subsequently linking none, one, or a plurality of objectives to none, one, or a plurality of measures; identifying patient criteria and enrolling patients from one or more investigator sites located in one or more countries; and integrating the clinical plan with a clinical plan execution application.

Abstract: One disclosed method includes receiving electronic health records (EHRs) associated with a first set of patients for a clinical trial of a health intervention; receiving electronic records representing profiles of patients likely to benefit from the health intervention; determining a first statistic for a first characteristic of the first set of patients and a second statistic for a second characteristic of the patients likely to benefit from the health intervention; and determining a gap in the first set of patients based on the first statistic and the second statistic.

Abstract: Systems and methods for data visualization are disclosed. For example, one disclosed method, includes receiving data from a clinical trial, retrieving data relevant to a study indicator (SI) from a plurality of data entities, and calculating a plurality of SI values, each calculated SI value based on the data from one of the plurality of data entities. The method further includes generating a graphical visualization that includes a graphical region indicating one or more ranges of values, a plurality of graphical indicators, each of the plurality of graphical indicators corresponding to one of the of plurality of SI values, wherein each of the plurality of graphical indicators is positioned within the graphical region based on the respective corresponding SI value and the one or more ranges of values, and displaying the graphical visualization.

Abstract: Methods are disclosed for determining whether organ toxicity, particularly cardiotoxicity, will occur in a patient selected for treatment with various kinase inhibitors, such as tyrosine kinase inhibitors, more particularly erbB inhibitors such as Herceptin. In addition, methods are disclosed for determining whether a potential drug is likely to produce a cardiotoxic effect. The methods involve analyzing lipid levels or the expression fatty acid oxidation enzymes, pAMP activated protein kinase, glucose uptake, to determine whether a fatty acid oxidation disorder is present. The identification of a fatty acid oxidation disorder can be used as a predictor of toxicity, especially cardiac toxicity, and as an indication that organ function should be carefully monitored if a drug such as a tyrosine kinase inhibitor is administered. Methods are also disclosed for protecting organs from metabolic stress and for the treatment of cells, such as adipocytes, to reduce their lipid content.

Abstract: Systems and methods for analytics on viable patient populations are disclosed. One disclosed method includes displaying a user interface control associated with a patient criteria, receiving a selection of a patient criteria through the user interface control, the patient criteria associated with a characteristic of a patient population, retrieving a subset of patient population source data from a patient population data source, the subset of patient population source data based at least in part on the selected patent criteria, and displaying a graphical representation of a patient population based on the retrieved subset of the patient population source data.

Abstract: Systems and methods for subject identification (ID) modeling are disclosed. A subject identification may be associated with information contained in one or more core domains such as a patient domain, a country domain, and/or an investigator domain. The domains can be generically designed such that data sources that are unknown at the time the domains are created can be managed. In this way, using generic structures that support the domains, data sources can be added and/or updated as additional information and/or data sources become available. Using various graphical user interfaces, a user can dynamically associate patient criteria, country criteria, investigator criteria, and/or other information with subject identifications. A subject identification may be associated with a specified capture date. Information contained in the various domains may be filtered such that only information contained in the domain on or before the capture date is available for the subject identification.