Monitoring and managing the safety of a product, and reducing the risk associated with adverse events, requires an early understanding of potential product safety concerns. PRA’s safety profiling/benefit risk assessment review is the most effective means of product safety profile monitoring.
The Safety and Medical monitoring teams use several methods to look for any safety signals. These include:
- JReview® software to search the clinical and safety data of the trial for potential safety signals
- A Standardized MedDRA Query (SMQ) tool to examine safety and clinical databases and identify any anomalies in relation to the expected outcome
- Analysis of patient profiles to determine if the adverse reaction is patient or trial specific (the Medical Affairs group routinely undertakes continuous patient reviews to detect safety issues)