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, systems, and apparatus, including computer programs encoded on computer storage media, for source data review and document compliance. The computer obtains a plurality of source documents, each source document comprising clinical trial information of the one or more clinical studies. The computer identifies, for each source document and by a natural language processing (NLP) model, a plurality of entities of the one or more clinical studies from the information related to the participants of the one or more clinical studies in the source document. The computer generates an updated NLP models configured to detect one or more events likely to have occurred among the plurality of entities, each event being associated with at least one entity from the plurality of entities. The updated NLP model is configured to update parameters in response to receiving a user input representing feedback to a model output from the updated NLP model.

Abstract: Methods, systems, and apparatus, including computer programs encoded on computer storage media, for generating operational plans. The method includes grounding a natural language processing (NLP) model in clinical trial context documents containing information related to execution of clinical trials; receiving a request to generate a clinical trial operational plan; by the NLP model and responsive to the received request, generating the clinical trial operational plan such that the generated plan includes content based on the clinical trial context documents; providing the generated clinical trial operational plan as an output; receiving revisions to the generated clinical trial operational plan, wherein the revisions applied to the generated clinical trial operational plan correspond to a revised clinical trial operational plan; and grounding the NLP model in the revised clinical trial operational plan.

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.