In our two-part interview, Cytel consulting statistician Ursula Garczarek reveals how rare disease development is benefitting from adaptive trial approaches. In this episode, Ursula shares her insights on current international regulatory perspectives. Ursula draws from he own considerable experiences, including defending adaptive trial statistical methodologies and their performance before EMA and FDA regulators.
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In our two-part interview, Cytel consulting statistician Ursula Garczarek reveals how rare disease development is benefitting from adaptive trial approaches. In this episode, Ursula shares her insights on current international regulatory perspectives. Ursula draws from he own considerable experiences, including defending adaptive trial statistical methodologies and their performance before EMA and FDA regulators.
Regulatory Perspective of Trial Design Innovations in Rare Disease Development
Cytel Podcasts
20 minutes
6 years ago
Regulatory Perspective of Trial Design Innovations in Rare Disease Development
In our two-part interview, Cytel consulting statistician Ursula Garczarek reveals how rare disease development is benefitting from adaptive trial approaches. In this episode, Ursula shares her insights on current international regulatory perspectives. Ursula draws from he own considerable experiences, including defending adaptive trial statistical methodologies and their performance before EMA and FDA regulators.
Cytel Podcasts
In our two-part interview, Cytel consulting statistician Ursula Garczarek reveals how rare disease development is benefitting from adaptive trial approaches. In this episode, Ursula shares her insights on current international regulatory perspectives. Ursula draws from he own considerable experiences, including defending adaptive trial statistical methodologies and their performance before EMA and FDA regulators.
