Pharmacovigilance in clinical trials is the monitoring of the serious adverse events that occur to the participating patients in a trial. Patient safety in clinical trials needs continuous monitoring. All adverse events are documented whether they are considered related or not to the study drug. Safety information from clinical studies is used to establish a drug’s safety profile in humans and is a key component that drug regulatory authorities consider in the decision-making as to whether to grant or deny market authorization (market approval) for a drug.
PvEdge offers a specific clinical trial pharmacovigilance functionality to handle life cycle risk-benefit management of medicinal products. PvEdge ensures better risk-benefit profiling of New Chemical Entities (NCEs), Investigational New Drugs (INDs) and new drugs on the market with functionalities facilitating early signal detections.
PvEdge also provides functionality for Ethics Committees to process SAE’s and generate CDSCO (Central Drugs Standard Control Organization) reports.