Medidata Solutions, Inc.

Glen De Vries

Isaac Wong

Michelle Marlborough

Matthew Szenher

Johnlouis Petitbon

Andrew Newbigging

Anthony Hewer

Jay B Smith

Andrew Smith

Joseph Rugilio

Bernardo Pontes

Chad Albers

Jay Smith

Joshua Hartman

Christopher Bound

Jonathan Lebowitsch

Benjamin Young

Barbara Elashoff

David Fenster

Jeevan Pendli

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.

Method and system for generating a master clinical database and uses thereof

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.

Apparatus and method for executing tasks

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.

Method and system for generating a unified database from data sets

A system for producing a clinical trial software application includes a processor, comprising a validation service and an audit service, and a platform, configured to prove-in an infrastructure on which the software application operates. The software application operating on the infrastructure is the same as the software application previously validated in a validation portal. The proving-in of the infrastructure comprises receiving infrastructure requirements from a software application supplier, building the software application supplier's instances, logging an installation report to the validation portal, and comparing the log to the frozen, validated software in the validation portal. The validation service is configured to validate the software application, freeze the validated software application in the validation portal, and generate documentation that satisfies compliance rules for the clinical trial software application. The validation service receives software code, testable requirements, and test results from a software application supplier and generates documentation regarding the validation of the software application. The audit service is configured to provide evidence of operational change management for a regulatory agency according to compliance rules of the regulatory agency. A method for producing regulatory-compliant software is also described and claimed.

Method and apparatus for producing regulatory-compliant software

Devices and methods are disclosed for use and processing of patient geolocation data in order to objectively determine a patient's territory as an artificially created digital biomarker while maintaining locational privacy. The objective determination of a patient's territory, defined as the area traversed in a specific time interval, can be used as a measurement of quality of life, as well as socio-economic contribution and benefit. Devices and methods are also disclosed for creating an artificial Overall Territory Activity Digital Biomarker based on Patient Activity Factors in addition to the Patient Territory Digital Biomarker, and which Overall Territory Activity Digital Biomarker also maintains locational data privacy. Furthermore, devices and methods are disclosed for capturing and transmitting digital biospecimens, the transformed geolocation data used to determine the Patient Territory Digital Biomarker. The digital biospecimen data can be subsequently used to create alternative, data privacy-preserving determinations of Patient Territory Digital Biomarkers, Patient Activity Factors, and/or Overall Territory Activity Digital Biomarkers.

Mobile health device and method for determining patient territory as a digital biomarker while preserving patient privacy

A method for producing regulatory-compliant software includes validating a software application and freezing the validated software application in a validation portal, proving-in an infrastructure on which the software application operates, and providing evidence of operational change management for a regulatory agency, which evidence comprises documentation that satisfies the agency's compliance rules. A regulatory-compliant software package is also described.

Generating a unified database from data sets

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.

Distributed randomization and supply management in clinical trials

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New York, NY, United States of America

Glen De Vries