Clinical teams and sponsors come to us when they need to:
Preparing properly up front can cut the number of review cycles needed.
Our services
Our founder, Lisa Kammerman, spent 24 years as a biostatistician at FDA’s Center for Drug Evaluation and Research (CDER), much of it as a Master Reviewer, followed by senior statistical roles in industry. That means we understand what regulators expect and what sponsors need.
About our founder
Find out what FDA and other regulators are likely to ask about your protocols, SAPs, briefing documents and clinical study reports, before you submit.
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We bridge the gap between the psychometricians who build instruments and the clinical trialists who design and analyse studies.
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Statistical expertise in designing and analysing clinical studies and in interpreting what the results mean.
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Invited speaker and biostatistics regulatory consultant at the CDKL5 Forum Annual Meeting, presenting on how to design clinical studies for small populations.
Chicago, Illinois, USA
Serving as regulatory statistics and clinical outcome assessment consultant. NUCOAT, led by David Cella, is developing core physical function outcome sets with support from a CDER pilot grant.
North Bethesda, Maryland, USA
Dr. Kammerman attended the forum and has written a summary of the sessions.