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Scrip Regulatory Affairs
Reflection and recommendation as EU and US scrutinise foreign trial data
21 July 2010
Ian Schofield

The integrity of clinical trial data is never far from the spotlight these days, with companies and regulators coming under increasing pressure to be more transparent in how they report and publish trial results.

Now attention is increasingly turning to the global stage. As the number of clinical trials conducted in developing countries increases, so does the need to ensure that any data from those trials that is used to support drug approval applications meets the standards of the country where approval is being sought...

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