Abstract
In Japan and other major East Asian countries in the global drug development scene, trial sites play a major role in conducting clinical trials by intervening between sponsors and investigators. The recent globalization of clinical development has been intensifying competition among the regions, trial sites, and investigators in terms of cost, speed, and quality. The quality of clinical trials-the key factor for competitiveness-is now being defined with a risk-based approach. Within this backdrop, Japanese trial sites now assume a new role in attaining the necessary amount of quality with increased efficiency. The author proposes strategies for Japanese trial sites to explore the potential to survive the competition. These strategies include further differentiation among trial sites and building in-house quality systems in hospitals. The strategies should be viable in other Asian countries with similar institution-based systems of conducting clinical trials.
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