Greater Paris Metropolitan Region
Experience in Rares Diseases : Paediatric Endocrinology, Endocrinology, Nephrology, Oncology. Experience in Medical Affaires, (PMS) Post Marketing Study/Phase 4 studies with budget managment and phasing Experience in Clinical Trials Managment (Phase III/IV) from Protocols synopsis to set up Investigators Meetings Management, meetings follow-up, Budget-Forcast follow up, Experiance in ESS (External Sponsors Studies) Experience in deveolpment of e-CRF. Experience in Rares Diseases , in biotech areas : Peadiatric Endocrinology (Growth Disorders,Metabolism, Puberty Disorders), Endocrinology, Nephrology and Oncology,Precocius Puberty Experience in Medical Affaires with KOL managment, organisation of experts boards, symposia, workshops, and scientific meetings. Managment of PMS in collaboration with CRO from study synopsis, to e-CRF with local set up and experts study borad. Managment of Phase 3/4 trials, from study synopsis to final, fesability studies, investigators seletion, investigators meetings,reports.
European KOL Interface (France, Italy, Spain, Portugal, Benelux, Grece, Romania) in Paediatric Endocrinology for therapeutics areas including Growth Retardation (r-hGH , r-hIGF-1) and Puberty diseases (AGnRH). Organization and coordination of Scientific Meetings, Workshops (stand alone meetings) in Paediatric Endocrinology area, selection of expert’s panels, scientific advisory board, with management and conception of scientific programs and management of speakers and moderators. Coordination of medical and scientific activities with European and International medical community. PMS (Post Marketing Survey) Study coordination with budget estimation/discussion, and follow-up. Phase 4 management from protocol synopsis to final protocol, investigators selection and set up, data management, monitoring (e-CRF management for observational study), reports assessment, and coordination with external partners CRO / Data Manager. Management of ESS (External Sponsor Study) from study synopsis to protocol discussion and set-up, with budget study evaluation and management (timelines) follow up and contract signature. (On line with Ethic and Compliance guidelines) Participation at internationals meetings (from clinical to basic science) in relation with therapeutics areas.