Read about the effort to review and recommend updates to ICH E3 and to develop clinical study protocol guidance. An open-access article is available online ahead of print at:

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I am a freelance medical writer providing a range of writing services, primarily to the pharmaceutical industry. I am a post-doctoral virologist working in clinical research since 1994, and specialising in regulatory medical writing from 1999. In my last salaried position (to September 2006), I managed UK Medical Writing for the world’s fifth largest Contract Research Organisation.

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