Avoiding Common Pitfalls in Clinical Trial Development

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ARTICLE SUMMARY:

The bar for medtech clinical trials keeps getting higher, both in the US and Europe, making the margin for error increasingly costly in terms of time and resources. New tools and approaches like adaptive design and big data can help companies avoid many commonly made mistakes and manage their trials more efficiently. By Vicki Anastasi, VP/Global Head, ICON plc’s Medical Device and Diagnostics Research Group

As the European Union implements more stringent device regulations and the US FDA sharpens its focus on safety and efficacy, sponsors face a steeper path to approval for most medical and diagnostic devices.

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