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.
All content for Cytel Podcasts is the property of Cytel and is served directly from their servers
with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
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.
East and the Independent Statistician: Answering the Toughest Development Questions
Cytel Podcasts
33 minutes
6 years ago
East and the Independent Statistician: Answering the Toughest Development Questions
Since it was first introduced over twenty years ago, the predictive simulation technology in today’s East has come a long way. Biotatistician Lukas Makris has come a long way, too, now an established Independent Consulting Statistician. In this role, Lukas now helps primarily emerging biotechs and specialty developers determine their optimal early stage clinical strategy. Biotech and specialty portfolio developers typically know their molecule or drug well, but are always seeking ...
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.
