Our team specialized in regulatory matters, offers support to the sites and researchers to carry out the closing process of the study by providing the following services:
• Assistance to prepare the final IRB review
• Assistance to prepare the final report of the FDA
• Assistance with the closing of the sponsor
• Archive of all study files
We have extensive experience in a variety of therapeutic areas by managing studies in USA, Latin America, Caribbean Islands and Central America. We have built strong business relationships with main researchers in several cities in the referred regions.
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