Our strong clinical and scientific knowledge in metabolic and inflammatory diseases, and in particular liver diseases, enables us to keep patient needs at the forefront, while integrating the various regulatory and economic requirements of health authorities.
We are equipped to define, set up, and manage clinical trials thanks to our solid medical, regulatory, and pharmaco-economic capabilities. Backed up by our network of clinical and scientific experts in the metabolism, hepatology, and gastroenterology fields, we create and implement the most appropriate development plans to demonstrate efficacy and safety in Man.
Thus, we have conducted more than twenty clinical trials, involving a total of over 1000 patients or healthy volunteers, in 15 different European or North American countries.
Thanks to rigorous protocol feasibility studies that allow us to best define patient populations and in particular inclusion/exclusion criteria, to a strict selection of clinical sites that meet recruitment requirements, and to the close monitoring of the entire study, each trial is optimized in order to provide pertinent results within the shortest timeframe.
At each step in the product development process, we meet all the regulatory requirements necessary in the run-up to market registration. Moreover, our regular contact with the health agencies (European Medicines Agency – EMA in Europe, Food and Drug Administration – FDA in the USA, and national health authorities) enables us to progress in keeping with the latest recommendations of the agencies.
Finally, we do not neglect the pharmaco-economic constraints that impact drug market access and evolution. Very early in the process, we involve world-renowned health economics specialists (HEOR – Health Economics and Outcomes Research), in order to help us to anticipate and facilitate market access for innovative treatments.