Expertise in
clinical research

Curriculum

Missions

Areas of
Expertise

Curriculum

• Senior Clinical Research Associate since 1995 (Merck / Theramex / Serono Laboratories)
• Trainer / teacher for training courses in partnership with IFIS on clinical research since 2005
• Medical representative from 1990 to 1995
• Degree of project manager in clinical research (2009) at the University of Paris VII
• Certificate of GCP training course / professional English A-Levels + 3 years of studies / hygiene and quality control of the product (1986)- Higher School of applied biology - Paris
• BTS diploma in biology (National School of Chemistry, Physics and Biology - Paris)
  

Missions related to medicines

• Phase I > Laboratoire Janssen Cilag (2010) = Influence of Rabeprazole on the magnitude of the antiplatelet action of Clopidogrel and bioequibalence study to compare two formulations of Haloperidol - Pharmacokinetic - pharmacogenomic - pharmacodynamic
  
• Phase I > Laboratoire Endotis Pharma (2010) = Study to assess the neutralization of EPX by avidin - Pharmacokinetic - pharmacodynamic
• Phase I > Laboratoire Merck / Theramex (2003 et 2007) = Pharmacokinetic and bioequivalence studies in Hormonology
  
• Phase II > Cegedim (2012) = Breast cancer: evaluate the efficiency of estramustine phosphate (Estracyt ®) on patients with metastatic breast cancer who have already received HER2-/RH + treatment with aromatase inhibitor
• Phase II > Laboratoire Neovacs (2011-2012) = Crohn’s disease : clinical efficacy, safety and immunogenicity of TNF alpha-Kinoïde
• Phase II > Laboratoire Ipsen (2011) = Growth Hormon therapy in pediatrics
• Phase II > Laboratoire Merck / Theramex (2006) = Effects of a new contraceptive pill (estradiol/NOMAC) on blood coagulation and fibrinolysis versus Miranova
• Phases II, III > French Group of Pneumology Cancerology (in progress) = Efficacy interms of survival without progression of various chemotherapy treatments
  
• Phase III > Merck / Theramex (2003) = Clinical Safety of an estro-progestatif association in Hormone replacement therapy in menopausal women
  
• Phases IV > Laboratoire Novartis (2012) = Submissions for a multinational Gilenya Pregnancy Exposure Registry in Multiple Sclerosis
  

Missions related in medical devices

• Phase I > Galilmedical (2012-2013) = Cryoablation for the palliation of painful bone metastases
• Phase I > Galilmedical (2012-2013) = Evaluating cryoablation of metastatic lung/pleura tumors of Patients – Safety and efficacy
  
• Phase III > French Group of Pneumology Cancerology (in progress) = comparison of bifractionated radiotherapy and monofractionated radiotherapy with concomitant chemotherapy in small cell lung cancers
  
• Phase III > Laboratoire Merck / Theramex (2000) = Efficiency and safety of an intrauterine device (IUD) for the contraception of women of childbearing age
  

Fields of expertise

• Feasibility, selection, investigator meetings, implementation, monitoring and closing of investigation centers
• Various fields of research: Phases I to IV on medicines and on medical devices
• Regulatory submissions for interventional studies and observational studies both in the field of medicine but also for medical devices
• Different therapeutic issues: oncology (breast, lung), gynecology, pulmonology, gastroenterology, osteoporosis, neurology, dermatology, pediatrics...
• Training on GCPs, training for CRAs and investigators
• Management of the quality plan related to audit and monitoring missions and compliance with the GCP’s
• Respect of the deadlines, the budget and reporting
• Respect of the data quality and reliability
• Guarantee of the professional and relational quality