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October 2017

ICH E6 R2: Talking Big Pharma’s Response To The Addendum

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This article was originally produced for Clinical Informatics News

The introduction and implementation of ICH E6 R2 has raised many questions surrounding operational risk-based approaches to clinical trial oversight. With the industry now in the process of getting to grips with more modernized practices for study conduct mandated by the guidance, this article addresses how sponsors are working to understand and interpret the obligations, as well as overcome the resulting challenges.