Sophie GOSSART

Management of phase 1 studies.
Responsibilities: Study set-up and follow-up/Site monitoring visits

Review of phase IIb and phase III study data - 4 phase III studies (26 countries – 150 to 200 sites – 1800 patients) and 1 phase IIb study (14 countries – 115 sites – 460 patients). Therapeutic area concerned: central nervous system. Compounds: new chemical entity and vaccine.

Overall management of international external phase 1 studies (first-in-man, multiple ascending dose, scopolamine, drug drug interaction, lactation studies) mono- and multi-centres in healthy young subjects, healthy elderly subjects and/or in patients, in interface with local study teams. Therapeutic areas concerned: central nervous system, pain, infectious disease, dermatology. Compounds: new chemical entities.
Responsibilities: Study set-up and follow-up until the clinical study report.

Management of in vitro, ex vivo and in vivo preclinical, external studies in pharmacology, toxicology and pharmacokinetic, in an international environment. Therapeutic areas concerned: Central Nervous System. Compound: new chemical entity.
Responsibilities: Study set-up and follow-up until the study report.