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Clinfoware® System Pharmacovigilance (PV) module offers a comprehensive solution for pre and post marketing safety surveillance. It facilitates signal detection and reporting of ICSRs, SUSARs and PSURs within different regulatory authority timelines. Its unique integration with other modules of the Clinfoware® System makes it one of the most effective Pharmacovigilance tools of its generation. It manages all aspects of Pharmacovigilance from configuration validation to international reporting.
Since the system is built on a central repository and database, the response time for collection of SAE data and corresponding action is dramatically reduced.
Key features:
Centralized safety data base
Signal detection
Reporting of ICSRs, SUSARs and PSURs
Report preparation, distribution and electronic submissions
Provides for Narratives and AE/SAE reconciliation process
Provides for report distribution