There’s no denying that studies are only as strong as their resulting data—and nonclinical studies produce a lot of data. A two-week study can easily generate more than 2 million results, while a two-year study can contain upward of 500 million data points. In an effort to process and easily interpret these massive data files, the FDA has developed SEND (Standard for Exchange of Nonclinical Data).
While it’s easy to think of SEND as another obstacle, it’s actually an opportunity to reveal new insights and gain efficiencies in data management. Exchanging information in a standard format can ease knowledge transfer between internal and external databases, as well as provide a common framework to support a more robust submission process. Coupled with the emergence of new tools for visualization and statistical analyses, SEND has the power to revolutionize the way data drive drug development decision making. Continue reading