Yannick BARDIE
Clinical Research expert
Professional Status
Freelancer
Open to opportunities
About Me
20 ans d’expérience en coordination et monitoring d’essais cliniques européens, avec des compagnies pharmaceutiques, fabricants de Dispositifs médicaux et des CROs.
Auteur de l’ouvrage « Essais Cliniques, du patient à l’objet de science »
Autonome et flexible, proactif, opérationnel, leadership
Double compétence industrielle et académique
Auteur de l’ouvrage « Essais Cliniques, du patient à l’objet de science »
Autonome et flexible, proactif, opérationnel, leadership
Double compétence industrielle et académique
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English : fluent
Spanish : good skills
Italian : understanding
Catalan : understanding
- Specialities : thrombosis, cardiovascular diseases, vaccins, urology, hepatology, lung cancer, medical imaging,obesity, anorexia, bulimia, oncology, neurology, diabetes
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Managment of clinical operations:
- coordination of CRAs and trainees
- conduct of Investigator meeting
- conduct of monitoring visits (site selection, kick off, monitoring, close-out)
- coordination of CRAs and trainees
- Communication with sponsors, investigators and competent authorities
- Quality assurance, compliance with GCP-ICH and concerned regulations
- Planning (project, ressources)
- Logistics
- Design of study documents (Protocol, Patient information, Informed Consent)
- Legal Representative in France for conducting clinical studies
- Project management and planification
- Point of view on the evolution of the clinical research in France and in the world. The opportunity of a reflection on a job which reaches maturity, at the age of reason and on a sector which globalizes and becomes industrialized. The opportunity of a debate also. Every public, 2 hours with questions answers and debate.
- The European directive 2001/20/CE on Clinical trials
- Health Marketing
- Specific product in development (blood components, medical devices)
- Role-playing workshop ( investigator meeting, inititation, monitoring and close-out visits)
- Professional training on the regulations for medical devices
- Clinical evaluation of performance and safety data of medical devices via a literature review according to the guide MEDDEV 2.7.1 rev3
- Healthcare
- Clinical Trials
- Clinical Research
- Medicine
- Pharmaceutical Industry
- Informatics
- Biotechnology
- Lifesciences
- Clinical Development
- Medical Devices
- Pharmaceutics
- Health Education
