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Hello GCSG Community,
I would like to understand the Direct-to-Patient model a bit more. Are regulatory agencies accepting this model, at least for the time being? What are the regulatory requirements per region? Are there any other considerations to keep in mind if a sponsor wants to rely on DTP/DFP shipments during the COVID-19 outbreak?
Alternatively, I know some sponsors are also working with local CROs to get IP to patients. If you can share any insights, best practices, or useful online resources/literature, that will be much appreciated.
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