Medidata Solutions, Inc.

Benjamin Young

Glen De Vries

Isaac Wong

Matthew Szenher

Andrew Newbigging

Jonathan Lebowitsch

Johnlouis Petitbon

David Fenster

A method for maintaining data in a substantiated state includes executing one or more services on the data message at a first node, annotating the message header with the services executed at the first node, transmitting the data message over a data network, and receiving the annotated data message at a second node. The annotation corresponds to the services executed at the first node, and the annotated data is extractable from the header for the execution of services at the second node. A system for maintaining data in a substantiated state is also described.

Method and system for maintaining data in a substantiated state

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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Manlius, NY, United States of America

Benjamin Young