Abstract: A method for determining a potential signal includes receiving a request for case data and a statistical value minimum. The method further includes selecting the case data from the central case warehouse based on the request and determining a statistical value based on the case data. The statistical value is at least one of: a case count, a proportional reporting ratio (PRR) value, a chi-squared value, an Empirical Bayes (EB) value, or an Interaction Singal Score (INTSS) value. The method further includes determining the potential signal associated with a specific adverse event code and a medical product identifier based on the statistical value and the statistical value minimum. The method further includes outputting the statistical value and the potential signal via the secure network.

Abstract: A method for collecting case data in a central case data storage system. The method includes receiving health agency case data from a health agency case repository and cleaning the health agency case data. The method further includes receiving multiple adverse event identifiers and medical product data. The method further includes combining the cleaned health agency case data with the medical product data and an adverse event identifier. The method further includes selecting trusted case data from a trusted case repository. The method further includes determining the combined health agency case data and the trusted case data at least partially match and generating one or more digital connections between the combined health agency case data and the trusted case data. The method further includes storing the combined health agency case data, the trusted case data, and the one or more digital connections in a central case data warehouse.

Abstract: Systems and methods for managing regulatory information. The system comprises a submission controller, a registration controller and a submission archive controller. The submission controller may manage a submission structure, and allow users to search for documents in a content management system and add the documents to the submission structure. The registration controller may manage product registration information and health authority interactions globally, and capture, view and take actions upon product registrations. The submission archive controller may allow users to access a complete history of regulatory submissions and correspondence globally, with an easy to use interface. The three controllers reside in a single system that allows them to interact seamlessly with each other.

Abstract: Systems and methods for managing regulatory information. The system comprises a submission controller, a registration controller and a submission archive controller. The submission controller may manage a submission structure, and allow users to search for documents in a content management system and add the documents to the submission structure. The registration controller may manage product registration information and health authority interactions globally, and capture, view and take actions upon product registrations. The submission archive controller may allow users to access a complete history of regulatory submissions and correspondence globally, with an easy to use interface. The three controllers reside in a single system that allows them to interact seamlessly with each other.