Medidata Solutions, Inc.

Mladen Laudanovic

Michael Elashoff

Jingshu Liu

Philip Beineke

Andrew Howland

Stephen Young

Mark Chandler

Vincent Marinelli

Anson Kring

Andrew Kopelman

Michael Cestone

Patricia Allen

Jenny Liu

An apparatus for automatically mapping a verbatim narrative to a term in a medical terminology dictionary includes a natural language processor and a comparator. The natural language processor processes terms from the medical terminology dictionary and from a medical coding decision database to generate a processed database that also includes the original terms from the medical terminology dictionary and the medical coding decision database. The natural language processor also processes the verbatim narrative. The comparator compares the processed verbatim narrative to the terms in the processed database and determines whether the processed verbatim narrative is an exact match to a term in the processed database. The verbatim narrative is mapped to the term in the medical terminology dictionary that corresponds to the term in the processed database that is an exact match. The verbatim narratives may include adverse event narratives, concomitant medication narratives, or other types of narratives. A method for automatically mapping a verbatim narrative to a term in a medical terminology dictionary is also described and claimed.

Apparatus and method for automatically mapping verbatim narratives to terms in a terminology dictionary

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.

Remote clinical study site monitoring and data quality scoring

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Mladen Laudanovic