Many U.S.-based life sciences companies outsource their clinical trial needs to laboratories outside of the U.S., including labs located in the European Union (EU). Others conducting clinical trials in the U.S. may be involved with the collection and processing of EU patients’ data in some other capacity. Despite the benefits of such international cooperation, these arrangements trigger an array of compliance obligations for U.S. companies under a number of EU laws[1], including the General Data Protection Regulation (GDPR) and its rules pertaining to data processing activities.

