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June 2018

ICH E6 R2 – The Clinical R&D Industry’s Response

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For decades now the complexity, cost, and duration of clinical development have been steadily increasing while profit margins for the industry have been dwindling. This crisis persists and is compounded by inefficient traditional methods of managing clinical trial quality. The ICH Good Clinical Practice Guidance Integrated Addendum (ICH E6 R2) provides a unified standard for the European Union, Japan, the United States, Canada, and Switzerland.