The International Society for Pharmacoepidemiology (ISPE) is a professional organization focused on studying the use and effects of medicines in defined populations.
ISPE supports methodological standards for observational research, real-world evidence generation, and population-level safety evaluations. Its guidance is frequently relevant to post-authorization safety studies and comparative effectiveness research. Sponsors and researchers use ISPE frameworks to strengthen study design rigor, bias control, and transparency in reporting. These methods complement clinical trial evidence by helping characterize long-term outcomes and safety patterns in routine care settings.