ABSTRACT
There has been substantial growth in the volume of research (both clinical and nonclinical) in recent years driven by the need for cures to life-threatening diseases and by the race to discover the next large, profitable drug or medical device. These advances in laboratory research have dramatically increased the volume of documents and data as well as the size and complexity of trials being conducted. In response, the Food and Drug Administration (FDA) has been compelled to perform more increasingly complex analyses and to ask more sophisticated questions of clinical investigators and sponsors in order to validate both the clinical and nonclinical trials data.
