Patents Assigned to Medidata Solutions, Inc.
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Publication number: 20140236668Abstract: A method for remote site monitoring includes receiving data from a clinical data site, calculating a site-metric risk indicator for each metric, and aggregating the site-metric risk indicators to generate a site-level data quality score. The site-metric risk indicator is calculated using a metric risk profile, which is based on historic clinical study data and study data received from clinical data sites. In some embodiments, each metric risk profile is based on experience levels of the sites. An apparatus for remote site monitoring is also described.Type: ApplicationFiled: February 21, 2014Publication date: August 21, 2014Applicant: Medidata Solutions, Inc.Inventors: Stephen Young, Vincent Marinelli, Mladen Laudanovic, Anson Kring, Andrew Kopelman
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Publication number: 20140229197Abstract: A distributed clinical trial system that provides configurability, reusability and integration of randomization and inventory configurations for different clinical trials with various electronic data capture (EDC) systems. The distributed clinical trial system includes a method of dispensing medication in a multi-arm clinical trial. In accordance with the method a subject identifier and a trial identifier are received from an electronic data capture system. The trial identifier indicates the multi-arm clinical trial, and the subject identifier indicates a subject enrolled in the multi-arm clinical trial. An arm identifier is retrieved from a database based on the received subject identifier. The arm identifier indicates an arm in the multi-arm clinical trial to which the subject is assigned. Thereafter, treatment is determined for the arm identifier based on a treatment design previously configured for the multi-arm clinical trial.Type: ApplicationFiled: April 16, 2014Publication date: August 14, 2014Applicant: Medidata Solutions, Inc.Inventors: Benjamin Young, Glen deVries, David Fenster, Jonathan Lebowitsch
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Publication number: 20140229198Abstract: A distributed clinical trial system that provides configurability, reusability and integration of randomization for different clinical trials with various electronic data capture (EDC) systems. The distributed clinical trial system includes a method of randomizing subjects in a multi-arm clinical trial. In accordance with a method, a subject identifier and a trial identifier are received from an EDC system. The trial identifier indicates the multi-arm clinical trial and the subject identifier indicates a subject enrolled in the multi-arm clinical trial. A randomization design algorithm for the multi-arm clinical trial is retrieved from a database using the received trial identifier. The randomization design algorithm is executed.Type: ApplicationFiled: April 16, 2014Publication date: August 14, 2014Applicant: Medidata Solutions, Inc.Inventors: Benjamin Young, Glen deVries, David Fenster, Jonathan Lebowitsch
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Patent number: 8799331Abstract: 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.Type: GrantFiled: August 23, 2013Date of Patent: August 5, 2014Assignee: Medidata Solutions, Inc.Inventors: Glen de Vries, Michelle Marlborough
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Patent number: 8793145Abstract: Protocol meta-models are made available to a protocol designer. Each protocol meta-model includes a list of preliminary patient eligibility attributes appropriate for a particular disease category. The protocol designer chooses the appropriate meta-model, and encodes the clinical trial protocol, including eligibility and patient workflow, within the selected meta-model. The resulting protocol database is stored together with databases of other protocols in a library of protocol databases. Once a patient is enrolled into a study, the protocol database indicates to a clinician what tasks are to be performed at each patient visit. These tasks can include both patient management tasks and data management tasks.Type: GrantFiled: August 28, 2013Date of Patent: July 29, 2014Assignee: Medidata Solutions, Inc.Inventors: Michael G. Kahn, Michael Mischke-Reeds
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Publication number: 20140188501Abstract: An apparatus for executing a task includes an authenticator to identify a user, a controller that can receive data from the user, and an authorizer to ensure that the user has access to applications used to execute the task. The controller is able to register or de-register the applications and then determine which if the registered applications should be used to execute the task. The controller then converts the data from the user so that it can be used by the application to execute the task. If the user selects a second task to be executed, the controller can determine which of the registered applications is to be used to execute the second task. Methods for executing multiple tasks are also described.Type: ApplicationFiled: November 6, 2013Publication date: July 3, 2014Applicant: Medidata Solutions, Inc.Inventors: Isaac Wong, Glen de Vries, Matthew Szenher, Jay B. Smith, Andrew Smith, Joseph Rugilio, Bernardo Pontes, Andrew Newbigging, Chad Albers
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Patent number: 8738397Abstract: A distributed clinical trial system that provides configurability, reusability and integration of randomization and inventory configurations for different clinical trials with various electronic data capture (EDC) systems. The distributed clinical trial system includes a method of randomizing subjects in a multi-arm clinical trial. In accordance with a method, a subject identifier and a trial identifier are received from an EDC system. The trial identifier indicates the multi-arm clinical trial and the subject identifier indicates a subject enrolled in the multi-arm clinical trial. A randomization design previously configured for the multi-arm clinical trial is retrieved from a database based on the received trial identifier. The subject identifier is assigned to an arm identifier of the multi-arm clinical trial based on the randomization design. The arm identifier indicates an arm of the multi-arm clinical trial to which the subject has been assigned.Type: GrantFiled: June 10, 2011Date of Patent: May 27, 2014Assignee: Medidata Solutions, Inc.Inventors: Benjamin Young, Glen de Vries, David Fenster, Jonathan Lebowitsch
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Patent number: 8706537Abstract: A method for remote site monitoring includes receiving data from a data site, converting those data into a site-level quality score using a metric risk profile, and calculating a risk indicator based on the site-level quality score. The metric risk profile may be based on historic data and study data, where the study data is received from a plurality of data sites. In some embodiments, converting the data includes normalizing a value of a metric by applying to it the metric risk profile and aggregating the normalized metric values to calculate the site-level quality score. An apparatus for remote site monitoring is also described.Type: GrantFiled: November 16, 2012Date of Patent: April 22, 2014Assignee: Medidata Solutions, Inc.Inventors: Stephen Young, Vincent Marinelli, Mladen Laudanovic, Anson Kring, Andrew Kopelman
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Publication number: 20140039921Abstract: Roughly described, a user instantiates protocol elements in a structured clinical trial protocol database and then draws from them in the development of one or more protocol related documents. The system helps the user select tasks to be performed during the study by reference to a historical database of tasks previously associated with similar protocols. The system automatically generates complex content from protocol elements in the database, and can render overlapping sets of protocol elements differently at different locations in the document. The system can automatically provide advisories indicating aspects of the document that still require completion or highlighting other issues that a sponsoring authority deems important for the document type. After all protocol elements are instantiated in the protocol database, it can then be used to drive the operation of most downstream aspects of the study.Type: ApplicationFiled: October 15, 2013Publication date: February 6, 2014Applicant: MEDIDATA SOLUTIONS, INC.Inventors: Carol A. Broverman, Michael Gary Kahn, Christopher Noon, Peter Leonard Abramowitsch
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Publication number: 20130346101Abstract: Protocol meta-models are made available to a protocol designer. Each protocol meta-model includes a list of preliminary patient eligibility attributes appropriate for a particular disease category. The protocol designer chooses the appropriate meta-model, and encodes the clinical trial protocol, including eligibility and patient workflow, within the selected meta-model. The resulting protocol database is stored together with databases of other protocols in a library of protocol databases. Once a patient is enrolled into a study, the protocol database indicates to a clinician what tasks are to be performed at each patient visit. These tasks can include both patient management tasks and data management tasks.Type: ApplicationFiled: August 28, 2013Publication date: December 26, 2013Applicant: Medidata Solutions, Inc.Inventors: Michael G. Kahn, Michael Mischke-Reeds
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Patent number: 8606599Abstract: An apparatus for executing a task includes an authenticator to identify a user, a controller that can receive data from the user, and an authorizer to ensure that the user has access to applications used to execute the task. The controller is able to register or de-register the applications and then determine which if the registered applications should be used to execute the task. The controller then converts the data from the user so that it can be used by the application to execute the task. If the user selects a second task to be executed, the controller can determine which of the registered applications is to be used to execute the second task. Methods for executing multiple tasks are also described.Type: GrantFiled: January 3, 2013Date of Patent: December 10, 2013Assignee: Medidata Solutions, Inc.Inventors: Isaac Wong, Glen de Vries, Matthew Szenher, Jay Smith, Andrew Smith, Joseph Rugilio, Bernardo Pontes, Andrew Newbigging, Chad Albers
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Patent number: 8571891Abstract: Roughly described, a user instantiates protocol elements in a structured clinical trial protocol database and then draws from them in the development of one or more protocol related documents. The system helps the user select tasks to be performed during the study by reference to a historical database of tasks previously associated with similar protocols. The system automatically generates complex content from protocol elements in the database, and can render overlapping sets of protocol elements differently at different locations in the document. The system can automatically provide advisories indicating aspects of the document that still require completion or highlighting other issues that a sponsoring authority deems important for the document type. After all protocol elements are instantiated in the protocol database, it can then be used to drive the operation of most downstream aspects of the study.Type: GrantFiled: April 29, 2013Date of Patent: October 29, 2013Assignee: Medidata Solutions, Inc.Inventors: Carol A. Broverman, Peter Leonard Abramowitsch, Michael Gary Kahn, Christopher Noon
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Patent number: 8533008Abstract: Meta-models are made available to clinical trial protocol designers. A meta-model includes a list of preliminary patient eligibility attributes appropriate for a particular disease category. The protocol designer chooses the appropriate meta-model, and encodes the clinical trial protocol, including eligibility and patient workflow, within the selected meta-model in a protocol database. The resulting protocol database is stored together with databases of other protocols in a library of protocol databases. Sponsors and individual clinical sites have controlled access to the protocols. Study sites make reference to the protocol database in order to perform patient eligibility screening. Once a patient is enrolled into a study, the protocol database indicates to the clinician what workflow tasks are to be performed at each patient visit.Type: GrantFiled: July 20, 2009Date of Patent: September 10, 2013Assignee: Medidata Solutions, Inc.Inventors: Michael G. Kahn, Michael Mischke-Reeds
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Publication number: 20130226610Abstract: Roughly described, a user instantiates protocol elements in a structured clinical trial protocol database and then draws from them in the development of one or more protocol related documents. The system helps the user select tasks to be performed during the study by reference to a historical database of tasks previously associated with similar protocols. The system automatically generates complex content from protocol elements in the database, and can render overlapping sets of protocol elements differently at different locations in the document. The system can automatically provide advisories indicating aspects of the document that still require completion or highlighting other issues that a sponsoring authority deems important for the document type. After all protocol elements are instantiated in the protocol database, it can then be used to drive the operation of most downstream aspects of the study.Type: ApplicationFiled: April 29, 2013Publication date: August 29, 2013Applicant: MEDIDATA SOLUTIONS, INC.Inventor: Medidata Solutions, Inc.
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Patent number: 8504380Abstract: Roughly described, a user instantiates protocol elements in a structured clinical trial protocol database and then draws from them in the development of one or more protocol related documents. The system helps the user select tasks to be performed during the study by reference to a historical database of tasks previously associated with similar protocols. The system automatically generates complex content from protocol elements in the database, and can render overlapping sets of protocol elements differently at different locations in the document. The system can automatically provide advisories indicating aspects of the document that still require completion or highlighting other issues that a sponsoring authority deems important for the document type. Alter all protocol elements are instantiated in the protocol database, it can then be used to drive the operation of most downstream aspects of the study.Type: GrantFiled: June 5, 2003Date of Patent: August 6, 2013Assignee: Medidata Solutions, Inc.Inventors: Carol A. Broverman, Michael G. Kahn, Christopher Noon
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Publication number: 20110307267Abstract: A distributed clinical trial system that provides configurability, reusability and integration of randomization and inventory configurations for different clinical trials with various electronic data capture (EDC) systems. The distributed clinical trial system includes a method of randomizing subjects in a multi-arm clinical trial. In accordance with a method, a subject identifier and a trial identifier are received from an EDC system. The trial identifier indicates the multi-arm clinical trial and the subject identifier indicates a subject enrolled in the multi-arm clinical trial. A randomization design previously configured for the multi-arm clinical trial is retrieved from a database based on the received trial identifier. The subject identifier is assigned to an arm identifier of the multi-arm clinical trial based on the randomization design. The arm identifier indicates an arm of the multi-arm clinical trial to which the subject has been assigned.Type: ApplicationFiled: June 10, 2011Publication date: December 15, 2011Applicant: MEDIDATA SOLUTIONS, INC.Inventors: Benjamin Young, Glen de Vries, David Fenster, Jonathan Lebowitsch
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Publication number: 20110161101Abstract: System and method of continuously analyzing trial data of an ongoing clinical trial is provided. A statistical analysis is performed on a trial database containing subject trial data without suspending the ongoing clinical trial. If the result of the statistical analysis does not exceed a predetermined threshold value, then the statistical analysis is repeated while the clinical trial is ongoing. In a blinded clinical trial, a grouped database is generated from the trial database and a blinding database prior to performing the statistical analysis. The grouped database groups the subject trial data according to the study groups.Type: ApplicationFiled: June 17, 2010Publication date: June 30, 2011Applicant: MEDIDATA SOLUTIONS, INC.Inventors: Edward F. Ikeguchi, Glen M. DeVries, Tarek A. Sherif, Edwin Goodman
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Publication number: 20110153358Abstract: The present invention includes a system and methods for planning a medical study. The system for planning a medical study includes a display device and a data store comprising a plurality of medical procedures for at least one of designing and executing a medical study. The system further includes a service delivery device operatively coupled to the display device and the data store. The service delivery device includes a processor and a memory for storing instructions.Type: ApplicationFiled: September 1, 2009Publication date: June 23, 2011Applicant: MEDIDATA SOLUTIONS, INC.Inventors: Rafael Alejandro Campo, Edward Stephen Seguine
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Patent number: 7752057Abstract: System and method of continuously analyzing trial data of an ongoing clinical trial is provided. A statistical analysis is performed on a trial database containing subject trial data without suspending the ongoing clinical trial. If the result of the statistical analysis does not exceed a predetermined threshold value, then the statistical analysis is repeated while the clinical trial is ongoing. In a blinded clinical trial, a grouped database is generated from the trial database and a blinding database prior to performing the statistical analysis. The grouped database groups the subject trial data according to the study groups.Type: GrantFiled: June 6, 2007Date of Patent: July 6, 2010Assignee: Medidata Solutions, Inc.Inventors: Edward F. Ikeguchi, Glen M. Devries, Tarek A. Sherif, Edwin Goodman
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Publication number: 20090319299Abstract: Techniques for collecting and reporting adverse events associated with a patient are disclosed. The techniques include providing a user interface to identify drug and medical conditions associated with the patient using standardized drug and medical terminology. The techniques also include generating and displaying a cumulative narrative of user selections on the interface. The cumulative narrative can be directly transmitted to one or more companies and/or and regulatory agencies.Type: ApplicationFiled: June 20, 2008Publication date: December 24, 2009Applicant: MEDIDATA SOLUTIONS, INC.Inventors: Glen Michael De Vries, Barton Lewis Cobert, Jordan Bergtraum