Abstract: The present disclosure relates generally to methods and materials for determining the responsiveness of a subject with a disease or disorder to an inhibitor of a receptor tyrosine kinase including, for example, IGF1R. Such methods may comprise obtaining a biological sample from the subject, assaying the biological sample for one or more PIK3CA mutations, determining if one or more PIK3CA mutations are present in the biological sample, and employing the determination of one or more PIK3CA mutations in the biological sample to predict responsiveness of the subject to the receptor tyrosine kinase inhibitor.

Abstract: Methods and systems for predictive analytics for site initiation and patient enrollment are disclosed. One method may include: receiving a user's selection of one or more parameters associated with a clinical trial; accessing a database of data associated with a plurality of previous clinical trials; comparing the one or more parameters to the previous clinical trials; determining one or more factors associated with the clinical trial based on the comparison; and displaying the parameters and the factors on a display.

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: Methods and systems to manipulate multiple selections against a population of elements are disclosed. One method may include: method for manipulating selections against a population of elements, the method comprising: receiving a plurality of data sets; determining one or more overlaps, each overlap comprising a common region between at least two data sets in the plurality of data sets; displaying a plurality of bars, each bar corresponding to a data set from the plurality of data sets; and for each of the one or more overlaps, displaying one or more elements in at least one of the plurality of bars, each element corresponding to a size of the common region between the at least two data sets.

Abstract: Systems and methods for data integration and standardization are disclosed. For example, one disclosed method comprises receiving first and second clinical trial data from first and second data stores, transforming the first clinical trial data and the second clinical trial data into operational data formats and storing the transformed data in a second operational data store; generating a first data entity stored in an integrated data format in an integrated data store; selecting a first data record from first clinical trial data in the first operational data format; identifying a second data record from the second clinical trial data in the second operational data format, wherein identifying the second data record is based at least in part on a determined association between the first data record and the second data record; and storing data from the first data record and the second data record in the first data entity.

Abstract: The invention relates to a method for assigning a risk rating to a medical product. The method includes assessing one or more threats associated with the medical product; assessing the level of experience with the medical product; and assigning a risk rating for the medical product to provide an indication of risk associated with the medical product. The method may be implemented as a webpage. For example, a new contraceptive may be assigned a risk rating of yellow for the general treatment population. This risk rating allows consumers to make an informed choice between different products on the basis of benefit versus risk, and help patients decide what steps they may wish to take to minimize their risk if they choose to take the new drug.

Abstract: Managing electrocardiogram (ECG) processing is described. ECGs are distributed to a technician system and/or a cardiologist system based on protocol data and one or more factors to promote processing efficiency for the ECGs. A modification to the protocol data can be received. Processed ECGs can be analyzed in view of the modification to identify ECGs for reprocessing. The identified ECGs can be reprocessed in accordance with the modification to the protocol data and, if applicable, the factors.

Abstract: The present disclosure relates generally to methods and materials for determining the responsiveness of a subject with a disease or disorder to an inhibitor of a receptor tyrosine kinase including, for example, IGF1R. Such methods may comprise obtaining a biological sample from the subject, assaying the biological sample for one or more PIK3CA mutations, determining if one or more PIK3CA mutations are present in the biological sample, and employing the determination of one or more PIK3CA mutations in the biological sample to predict responsiveness of the subject to the receptor tyrosine kinase inhibitor.

Abstract: The present disclosure provides methods and compositions for treating a disease or disorder in a subject, the method comprising, administering to the subject a therapeutically effective amount of one or more receptor tyrosine kinase inhibitors and a therapeutically effective amount of one or more inhibitors of the dihydrofolate reductase (DHFR) pathway including, for example, methyltransferase inhibitors.

Abstract: According to various embodiments of the present invention, a data management process is provided that manages ECG data collection, review, and reporting in an efficient and secure manner by utilizing biometric checks, quality control measures, and workflow control systems that route data based on a variety of factors to efficiently complete the measurement and analysis process.

Abstract: Embodiments of the present invention provide systems and methods for scheduling patients in an organized and uniform way using a batch follow-up system. Such batch follow-up methods help a research site conducting research to prepare one or more of study supplies, patient charts, study goals, and data collecting requirements in preparation for the batch follow-up visits. Embodiments of the invention also relate to systems and methods for communicating initial and follow-up visit dates to patients. In certain instances, various communications (e.g., between the patients and the study site or between the study site and the study sponsor) may be electronic communications. Methods of scheduling and sequencing patient visits may be conducted over a network wherein reminders about follow-up visits are electronically generated.

Abstract: Methods and systems for allocating representatives, such as clinical research associates (CRAs), to sites. One embodiment comprises a method for allocating CRAs to sites by determining for each CRA the first segment travel time from a starting location to a first node associated with a CRA, and the second segment travel time from the first node to a plurality of second nodes, wherein each second node is geographically associated with a site, determining the third segment travel time from each second hub to its corresponding site(s), for each CRA determining the aggregate travel time to each site by adding at least the first, second and third travel segments, for at least some of the CRAs and at least some of the sites, evaluating the aggregate travel times between CRAs to each of the sites, and allocating a CRA to allocate to each site based in part on the travel times.

Abstract: Certain embodiments of the present invention provide clinical site information to clinical trial managers to support clinical trial management. One embodiment is a method for providing information in response to an inquiry. A plurality of site attributes is received. The site attributes can include information regarding the sites that may include clinical trial history, identification, or other site information. Each site attribute includes data elements that are associated with clinical trial sites. A site attribute is identified and a score is determined for each data element of the identified site attribute. An inquiry for clinical trial site information is received. The plurality of data elements are searched to identify at least one clinical trial site based on the inquiry. Information associated with the identified at least one clinical trial site is provided.