The CDISC-SEND data standard has opened new avenues for collaborative development of methodologies that enable cross-study analyses of toxicology study data. Initiatives led by organizations such as PHUSE, TransCelerate, and the European Union’s Innovative Health Initiative have brought together interdisciplinary teams of scientists to develop and publish innovative approaches for leveraging SEND datasets. These efforts aim to enhance the detection and characterization of safety signals in nonclinical toxicology studies. The resulting large-scale analytical methods provide a strong foundation for building predictive models that more accurately characterize the toxicological profiles of investigational therapeutics. By integrating chemical, pharmacological, toxicological, clinical, and epidemiological data, interdisciplinary teams can now construct models that offer a comprehensive and holistic view of drug safety throughout the development lifecycle.
