ABSTRACT
Clinical development plans today typically take into account the marketing authorization requirements for more than one country in order to maximize the return on investment for a compound’s research and development. The use of “foreign data” as pivotal and supportive data to a New Drug Application (NDA) or a Marketing Authorization Application (MAA) requires the assurance of common or uniform standards of quality and practices. ICH Good Clinical Practices (GCP) can provide some of these assurances, but in reality, it is the diligence of the research teams that ensures a global trial employing up to hundreds of sites on several continents will produce a meaningful database through which sound analyses and decisions can be made.
