PhUSE, the Pharmaceutical Users Software Exchange, is an organization run by a global team of volunteers, including members of our in-house Inotiv SEND team. PhUSE provides a platform for discussing topics related to both clinical and non-clinical studies, with the goal of supporting health product development and regulatory review, ultimately leading to safe and effective products for those in need. PhUSE is recognized as the industry voice to regulatory agencies and standards organizations, such as the US Food and Drug Administration (FDA), the European Medicines Agency, and the Clinical Data Interchange Standards Consortium. To learn more about PhUSE, click here.

SEND, the Standard for Exchange of Nonclinical Data, provides guidelines for organizing, structuring, and formatting nonclinical data for exchange between organizations such as sponsors, clinical research organizations (CROs), and for submission to regulatory authorities like the FDA. This standardized formatting enables researchers and regulators to use visualization tools to analyze data effectively and efficiently.

Computational science uses computers and mathematical models to analyze large amounts of data. In biomedical research, this means using these tools to understand complex biological processes and improve drug development. It’s essential for making new treatments safer and more effective.