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.

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 Announces Availability of EnForeSys 2.0 More than half of today’s clinical studies take longer than expected to achieve their enrollment targets, often leading to discontinued trials and expensive failures. EnForeSys is the decision tool using modern simulation methods to accurately predict recruitment milestones. Armed with a reliable probability of success, rest assured your trial will achieve target enrollment on time and on budget. New features “Interactive Planner" mode for iterati...