Vincent Cabane Email & Phone Number

Preclinical and clinical development of innovative medical technologies:1. Clinical strategy: design of clinical development programs following requirements from Research and Development, Regulatory Affairs, Marketing and Reimbursement.2. Clinical Investigation Plans: design of individual protocols, case report forms (paper as well as electronic), patient informed consents.3. Submissions to Ethics Committees and Competent Authorities across Europe and North America.4. On-site support: investigators training, initiation visits, attendance to surgical interventions, data collection and monitoring.5. Data management and data analysis in partnership with Contract Research Organizations and biostatisticians.6. Medical writing: clinical study reports, scientific publications (medical abstracts and manuscripts), regulatory submissions, public presentations.7. Safety and effectiveness assessment for regulatory agencies including European Notified Bodies (CE mark) and American Food and Drug Administration (510(k), IDE and PMA).Expertise in electronic systems for data capture: optimization of investigational plans, design of data workflows, technical project specifications, and implementation and deployment of clinical studies in liaison with internal teams.Current experience in:• Cardiovascular: arteriosclerosis, cardiac arrhythmia, critical limb ischemia, structural heart disorders• ENT laryngology: dyspnea, dysphagia, swallowing disorders• Oncology: bone, head & neck, and prostate cancer• Orthopedics: degenerative disc disease, vertebral compression fractures• Urology: benign prostatic hyperplasia, urinary lithiasis

Listed skills include Clinical Trials, Medical Devices, Clinical Research, Clinical Development, and 24 others.