As in the Clinical Team, Adeline provides leadership and supervision to internal and external cross-functional teams related to Early Access Program. She is responsible for managing the requirements and submissions for Early Access Programs in the USA and Europe.
Adeline has a deep knowledge of program management principles, vendor oversight and regulatory requirements. She collaborates with key stakeholders to ensure compliant execution of EAP objectives, addressing health care practionners questions, facilitate review and approval of EAP protocols and related documents Strategic mindset for a proper set up of Early Access Programs
As a Clinical Trial Director, Adeline is responsible for supervising the study team to ensure that project scope, timelines and budget are met. She is also responsible for managing and coordinating all phases of clinical trial-related activities concerned with the planning, conduct and completion of clinical projects (including protocol feasibility, monitoring, investigational product supply, vendor selection, data management, biostatistics, site close-out visits and the preparation of clinical study reports), whilst ensuring GCP and local regulatory requirements are adhered to.
Adeline brings to the role more than 10 years of experience in building relationships with investigators and working within tight timelines, gained as a sponsor of clinical trials, and from having worked in the CRO environment. During that time, she was responsible for developing protocols and CRFs, providing support to monitors by creating study manuals and monitoring guidelines, budget planning, forecasting and follow-up, data management and statistical activities. She was also involved in vendor selection and organized many bid defence meetings.
Adeline has an expertise in conducting studies in oncology, endocrinology, gynecologic disorders, neurology, aesthetics and paediatrics.
Adeline has a Bachelors degree in Biochemistry at the University of Sciences and Technology of Lille and, a Masters in Drug Design at the Institute of Pharmaceutical Chemistry of Lille (2006).
She is based in our Boulogne office.