I am a mathematician and statistician. I hold a Master degree of Mathematics from the University of Lyon 1, supplemented by numerous professional training courses and more than 20 years of experience in the field of clinical trials.
I have had the opportunity to work within research centres, CROs and pharmaceutical laboratories, and I have been offering my services as a consultant since 2011 thanks to my company MDSTAT Consulting. I have specialized particularly in pre-AMM studies (phase I to III) and have worked in many different therapeutic areas (with more experience in Ophthalmologist/Neuro/Gastro/rare diseases). I am also used to working with Animal Health Research and Device, of which I am truly familiar with.
In recent years, I have mainly focused my activity on support for the global clinical development strategy (phase 2 / phase 3), pivotal phases and regulatory methodological exchanges (with EMA and FDA). Since 2019, I also am an external consultant in the Strategic Consulting team of Cytel Inc.
Moreover, I organize annual training in clinical trial methodology for statisticians and non-statisticians, and am regularly asked to join an expert committee (DMCs) during the follow-up of the studies (in particular adaptive designs).
I am responsive and experienced. I will provide you with methodological support suited and suitable to your projects, regardless of the stage of clinical development of your products.