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Methods and systems for predictive clinical planning and design and integrated execution services

  • US 9,224,224 B2
  • Filed: 06/24/2013
  • Issued: 12/29/2015
  • Est. Priority Date: 06/22/2012
  • Status: Active Grant
First Claim
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1. A non-transitory computer-readable medium embodying computer program code for developing a plan for a clinical trial, the computer program code comprising computer executable instructions for:

  • receiving schema information for the clinical trial from a user interface, the schema information associated with one or more patients for the clinical trial, one or more investigators for the clinical trial, or enrollment criteria for the clinical trial;

    generating a schema based at least in part on the schema information, the schema including at least one treatment arm and at least one visit structure for the clinical trial;

    receiving patient burden information for the clinical trial, the patient burden information being associated with the at least one visit structure and comprising information about measures to be performed on or by a patient during one or more visits during the clinical trial;

    calculating a burden score representing a burden imposed on the patient from participation in the clinical trial, the burden score calculated from the patient burden information;

    generating a graphical representation of the schema and the burden score; and

    storing the schema and the burden score in a database.

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