Abstract: Aspects of the subject matter described in this specification are embodied in systems and methods that utilize machine-learning techniques to evaluate clinical trial data using one or more learning models trained to identify anomalies representing adverse events associated with a clinical trial investigation. In some implementations, investigation data collected at a clinical trial site is obtained. A set of models corresponding to the clinical trial site is selected. Each model included in the set of models is trained to identify, based on historical investigation data collected at the clinical trial site, a distinct set of one or more indicators that indicate a compliance risk associated with the investigation data. A score for the clinical trial site is determined based on the investigation data relative to the historical investigation data. The score represents a likelihood that the investigation data is associated with at least one indicator representing the compliance risk.

Abstract: Aspects of the subject matter described in this specification are embodied in systems and methods that utilize machine-learning techniques to evaluate clinical trial data using one or more learning models trained to identify anomalies representing adverse events associated with a clinical trial investigation. In some implementations, investigation data collected at a clinical trial site is obtained. A set of models corresponding to the clinical trial site is selected. Each model included in the set of models is trained to identify, based on historical investigation data collected at the clinical trial site, a distinct set of one or more indicators that indicate a compliance risk associated with the investigation data. A score for the clinical trial site is determined based on the investigation data relative to the historical investigation data. The score represents a likelihood that the investigation data is associated with at least one indicator representing the compliance risk.

Abstract: Methods and systems to automatically construct a clinical study site visit report (SVR), conduct the SVR, evaluate the SVR in real-time, and provide feedback while the SVR is being conducted. Responses to the SVR include user-selectable answers and natural language notes. Each response is evaluated as it is submitted based on a combination of pre-configured rules and a computer-trained model. If an anomaly is detected and is not already captured in the SVR, an alert is generated during performance of the SVR. The alert may include recommended remedial action.

Abstract: Aspects of the subject matter described in this specification are embodied in systems and methods that utilize machine-learning techniques to evaluate clinical trial data using one or more learning models trained to identify anomalies representing adverse events associated with a clinical trial investigation. In some implementations, investigation data collected at a clinical trial site is obtained. A set of models corresponding to the clinical trial site is selected. Each model included in the set of models is trained to identify, based on historical investigation data collected at the clinical trial site, a distinct set of one or more indicators that indicate a compliance risk associated with the investigation data. A score for the clinical trial site is determined based on the investigation data relative to the historical investigation data. The score represents a likelihood that the investigation data is associated with at least one indicator representing the compliance risk.