公开(公告)号：US11023679B2

公开(公告)日：2021-06-01

申请号：US15443828

申请日：2017-02-27

申请人： Medidata Solutions, Inc.

发明人： Patricia Allen ,  Andrew Howland ,  Philip Beineke ,  Mark Chandler ,  Michael Elashoff ,  Mladen Laudanovic ,  Jingshu Liu ,  Michael Cestone ,  Jenny Liu

IPC分类号： G16H15/00 ,  G06F40/242 ,  G06F40/247 ,  G06F40/279 ,  G16H10/20

摘要： 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.

公开(公告)号：US20140236668A1

公开(公告)日：2014-08-21

申请号：US14186791

申请日：2014-02-21

申请人： Medidata Solutions, Inc.

发明人： Stephen Young ,  Vincent Marinelli ,  Mladen Laudanovic ,  Anson Kring ,  Andrew Kopelman

IPC分类号： G06Q10/06 ,  G06F19/00

CPC分类号： G06Q10/0635 ,  G06Q10/10 ,  G06Q50/22 ,  G16H10/20

摘要： 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.

摘要翻译： 用于远程站点监测的方法包括从临床数据站点接收数据，为每个度量计算站点度量风险指标，并且聚集站点度量风险指标以生成站点级数据质量得分。 使用度量风险简档计算现场指标风险指标，该风险指标基于临床数据站点收集的历史临床研究数据和研究数据。 在一些实施例中，每个度量风险简档基于站点的经验水平。 还描述了用于远程站点监视的装置。

公开(公告)号：US20170220773A1

公开(公告)日：2017-08-03

申请号：US15014849

申请日：2016-02-03

申请人： Medidata Solutions, Inc.

发明人： Angel Janevski ,  Mladen Laudanovic

IPC分类号： G06F19/00 ,  G06Q50/22 ,  G06Q10/06

CPC分类号： G16H10/20 ,  G06Q10/067 ,  G06Q50/22

摘要： An improved system for tracking the progress of a clinical study includes a classifier generator, a classifier application subsystem, a study stage annotation subsystem, a progress status models generator, an aggregation module, and a progress status evaluation subsystem. The classifier generator automatically generates clinical data element classifiers by evaluating clinical data containers and clinical study stage attributes across clinical studies; the classifier application subsystem applies the clinical data element classifiers to classify clinical data elements into pre-determined categories; the study stage annotation subsystem uses the clinical data element classifiers and the classified clinical data elements to determine clinical study stages; the progress status models generator generates at least one progress status model based on the clinical study stages, the aggregation module selects and aggregates the classified clinical data elements and clinical study stages; and the progress status evaluation subsystem computes the state of at least one progress status model. The progress status evaluation subsystem generates at least one progress status of the clinical study by using the clinical data element classifiers and clinical data to compare contextualized study properties of one or more associated clinical study stages. An improved method for tracking the progress of a clinical study is also described and claimed.

公开(公告)号：US20160171181A1

公开(公告)日：2016-06-16

申请号：US14565607

申请日：2014-12-10

申请人： Medidata Solutions, Inc.

发明人： Stephen Young ,  Mladen Laudanovic ,  Anson Kring

IPC分类号： G06F19/00 ,  G06Q50/22

CPC分类号： G06Q50/22 ,  G16H10/20

摘要： A system for assessing a clinical trial site's subject event reporting rate includes a subject event and visit count processor and a site subject event rate processor. The subject event and visit count processor receives subject event and subject visit data from a plurality of clinical trial sites and calculates for each clinical trial site a total visit count and a total subject event count. The site subject event rate processor receives the total visit count and total subject event count for each clinical trial site, calculates a trial-level subject event rate for the clinical trial, calculates for each clinical trial site an expected total subject event count based on the clinical trial site's total visit count and the trial-level subject event rate, and compares for each clinical trial site the expected total subject event count to the total subject event count to assess the probability that the clinical trial site is under-reporting or over-reporting subject events.

摘要翻译： 用于评估临床试验站点的主题事件报告率的系统包括主题事件和访问计数处理器和站点主体事件速率处理器。 主体事件和访问计数处理器从多个临床试验站点接收主题事件和主体访问数据，并且为每个临床试验站点计算总访问次数和总被摄体事件计数。 站点主体事件速率处理器接收每个临床试验站点的总访问次数和总主题事件计数，计算临床试验的试验级主题事件率，根据每个临床试验站点的预期总被摄体事件计数计算 临床试验地点的总访问次数和试验级别的事件发生率，并将每个临床试验点比较预期的总体事件计数与总体事件计数，以评估临床试验点的报告不足或过高的概率， 举报主题事件。

公开(公告)号：US20180246876A1

公开(公告)日：2018-08-30

申请号：US15443828

申请日：2017-02-27

申请人： Medidata Solutions, Inc.

发明人： Patricia Allen ,  Andrew Howland ,  Philip Beineke ,  Mark Chandler ,  Michael Elashoff ,  Mladen Laudanovic ,  Jingshu Liu ,  Michael Cestone ,  Jenny Liu

IPC分类号： G06F17/27 ,  G06F17/28 ,  G06F19/00

CPC分类号： G06F19/326 ,  G06F17/2735 ,  G06F17/2765 ,  G06F17/2795 ,  G16H10/20 ,  G16H15/00

摘要： 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.

公开(公告)号：US20160085943A1

公开(公告)日：2016-03-24

申请号：US14492597

申请日：2014-09-22

申请人： Medidata Solutions, Inc.

发明人： Glen de Vries ,  Mladen Laudanovic ,  Angel Janevski

IPC分类号： G06F19/00

CPC分类号： G16H10/20

摘要： A method for monitoring clinical trial progress includes calculating progress curves for clinical trial states. Calculating a progress curve includes assigning values to events for a datapoint in the clinical trial, generating or building pairs of values for each consecutive sequence of the events, summing up the values of pairs of events corresponding to a state change, and determining a state for the datapoint based on the sum of the values. Monitoring clinical trial progress then includes calculating a second progress curve for another clinical trial state and comparing the delay between points of the progress curves. A system for monitoring clinical trial progress is also described.

摘要翻译： 监测临床试验进展的方法包括计算临床试验状态的进展曲线。 计算进度曲线包括为临床试验中的数据点的事件分配值，为事件的每个连续序列生成或构建一对值，将与状态变化相对应的事件对的值相加，并且确定 数据点基于值的总和。 监测临床试验进展包括计算另一个临床试验状态的第二个进展曲线，并比较进度曲线点之间的延迟。 还描述了用于监测临床试验进展的系统。

公开(公告)号：US08706537B1

公开(公告)日：2014-04-22

申请号：US13679533

申请日：2012-11-16

申请人： Medidata Solutions, Inc.

发明人： Stephen Young ,  Vincent Marinelli ,  Mladen Laudanovic ,  Anson Kring ,  Andrew Kopelman

IPC分类号： G06Q10/00

CPC分类号： G06Q50/22 ,  G06F19/00 ,  G06F19/3418 ,  G06Q10/10 ,  G16H50/30

摘要： 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.

摘要翻译： 用于远程站点监控的方法包括从数据站点接收数据，使用度量风险简档将这些数据转换为站点级质量得分，以及基于站点级质量得分计算风险指标。 度量风险简档可以基于历史数据和研究数据，其中从多个数据站点接收研究数据。 在一些实施例中，转换数据包括通过向其应用度量风险简档来归一化度量值，并聚合归一化度量值以计算站点级质量得分。 还描述了用于远程站点监视的装置。