Innovative Plan Reopens Sites Three Months Earlier Than Expected After FDA Clinical Hold

Syneos Health™ was responsible for the management of six oncology studies with novel immunotherapy treatment. With sites engaged in start-up and active treatment, the client received an FDA notification that the IND applications were placed on clinical hold, restricting screening and treatment of all new and existing subjects. It was critical that the sites were informed immediately.

The clinical hold put the overall study enrollment timelines at risk, and if active subjects discontinued as a result, they would need to be replaced. Syneos Health had to implement an innovative strategy to ensure screening activities and treatment could resume as soon as possible to minimize the impact of the hold.

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