Cough monitoring has emerged as an increasingly common practice in research studies and drug development in recent years to objectively measure changes in subjects’ cough. As drug developers consider including cough frequency as an endpoint in their studies, understanding the current regulatory pathway and the FDA’s validation requirements is essential.
To support trial sponsors, we’ve developed an explainer PowerPoint that overviews the FDA’s validation requirements for semi-automated cough counting, as this approach offers a clear regulatory pathway. This explainer overviews the steps in semi-automated cough counting and how validation is demonstrated for each of these steps. It also details how Strados Labs’ meets these requirements—offering drug developers a cough monitoring solution that can be trusted in pharmaceutical clinical trials, including for primary endpoints.
View the slides below to gain a deeper understanding of the validation expected from the FDA for cough monitoring and how Strados Labs can support your trial’s success.
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