Safety As A Science: Analytics For Trial Safety And Pharmacovigilance

Clinical trials can expose both predicted and unexpected safety signals. Surveillance must therefore look beyond expected adverse events to detect possible safety signals. Ruling out or exposing safety events through accelerated analytics can spare the rigorous data management and statistical resources required for submission while ensuring due diligence in clinical oversight of trial participant safety. Interim and final submission reporting can then focus on those safety events that are shown to be significant to the submission.

Multiple data sources are available during trial conduct. Those data, accessible early in trial conduct, provide opportunities to adjust trial data collection practices and site training.  Furthermore, trial amendment or clinical program strategy for upcoming clinical trial designs can be modified in response to emerging questions. Access and automated aggregation of clinical data is essential to enable this early understanding of emerging safety signals while implementing and executing a clinical development program.\

From CRF safety data review to operational accelerators to in-house safety data, a pharmacovigilance database can offer crucial insights into an organization’s clinical programs. PerkinElmer Informatics, a global company serving multiple industries, has developed several key analytics solutions for the biopharmaceutical industry, including pharmacovigilance, medical review, risk-based monitoring, and other core platforms powered by Tibco Spotfire®️.