Services

Regulatory Affairs

As a result of managing a large number of clinical trials worldwide, GRS has gained significant global regulatory experience. We are very familiar with the current requirements for regulatory approval of trials in 32 countries, which helps expedite regulatory approval as well as shorten time needed for local IRB/EC evaluation. Study start-up is tailored to the local regulatory requirements for each site participating in the study, reducing lead time required prior to enrolling participants.

GRS has a streamlined process for the collection of regulatory documents, which eliminates errors and requests for corrected documents. GRS tracks, reviews, processes, stores and follows up to ensure the collection of all regulatory documentation. In addition, GRS documents the dates of submission to the committees and tracks all IRB/EC decisions.