To support various aspects of drug safety monitoring and management.
PV works
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🔖Safety Databases: Dedicated software systems used to capture, store, and manage adverse event data.
Example:
✴️ARGUS (Oracle): Widely used commercial safety database for managing adverse event reports, signal detection, and safety data analysis.
🔖Signal Detection and Data Mining Tools: Analyze safety data to detect potential safety signals.
Example:
✴️Empirica Signal (Oracle): Utilizes statistical algorithms and data mining techniques to identify potential safety signals from large safety databases.
✴️Risk Management and Pharmacovigilance Planning Tools: development and implementing risk management plans and strategies. Example:
✴️VWeb (EMA): Web-based application that allows #pharmaceutical companies to submit risk mnagement plans and share pharmacovigilance-related data with regulatory authorities.
✴️Data Analytics and Reporting Tools: Enable analysis and reporting of safety data for signal detection, periodic safety update reports (PSURS), and aggregate safety analysis.
List of software used in PV:
✴️Oracle Argus Analytics: An analytics and reporting module integrated with the Argus safety database for generating safety reports and analyzing safety data.
✴️Data Integration and Interoperability Tools: Facilitate the integration and exchange of data between different pharmacovigilance systems and databases. Example:
✴️OpenClinica: An open-source clinical data management system that can be customized for pharmacovigilance data collection and management.
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