ABSTRACT
Self-evidently, national practices, laws, and language will lead to local variations. Particularly in the United States, the Food and Drug Administration (FDA) requirements will, for instance, result in provisions that are not found in the European Union (EU). Heightened legal sensitivity in the United States to issues of liability and litigation risks in general results in somewhat more detailed contractual documentation than would normally be seen in Europe. In addition, it has been in the United States that we see glimmerings of a greater degree of risk sharing between CROs and sponsors. To the extent these relationships involve technology transfer, wholly new considerations, such as the licensing of patents and know-how, will come into play.
