Clinical safety concerns with the collection, processing, and analysis of adverse event reports from investigators using the product in the tightly controlled setting of clinical research design.
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 a 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.