Cytel Podcasts
The Cytel global team of professionals is here to help you address an array of challenges when conducting drug development. Whether you face a complex statistical issue or the need for knowledgeable collaborators to handle biometrics and trial implementation, Cytel has skilled professionals available when you need them.
Cytel Podcasts
Regulatory Perspective of Trial Design Innovations in Rare Disease Development
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Ursula Garczarek, Cytel Strategic Consulting
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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.