Real-World Evidence Conference

Parexel is conducting a post-authorization safety study (PASS) and registry build to assess the long-term safety of a drug treating a rare neurological disease. The study, mandated by EMA's PRAC, aims to characterize and quantify potential risks and address queries from European regulators. With the development of a novel data ingestion and analysis engine to process over 15 disparate sources, data is transformed into a common model for segmentation and analysis. This creative approach allows our customer to effectively assess product safety in line with regulatory mandates while maintaining access to the novel medicine for the rare and vulnerable patient population.