Thomas has been in the medical device industry for 5 years as a Medical Monitor and Leader in the Clinical Safety environment. He has focused on medical devices specifically in Aortic Repair, Structural Heart Disease, Peripheral- and Neuro-vascular disease.

He has assisted Sponsors in their CE marking discussion with Notified Bodies and has worked with them to manage global device recalls and cooperate with DSMBs (Data Safety Monitoring Boards).

Thomas graduated with a Master in Medicine from the University of Ghent.

CORE COMPETENCIES

• Medical Monitoring in a variety of therapeutic areas, including cardiovascular, oncology, neurology and orthopaedics
• Managing CEC (Clinical Endpoint Committee) and DSMB (Data Safety Monitoring Board) activities for complex device trials, including charter development and safety related CRF (Case Report Form) development
• Providing medical leadership and mentorship to the safety and clinical team
• Overseeing and resourcing for safety related projects
• Expertise in EMEA, US and APAC Safety reporting requirements
• Reviewing of Clinical Evaluation Plans & Reports, Clinical Study Reports, manuscripts and clinical protocols
• Helping Sponsors with questions from Regulatory bodies such as FDA (Food and Drug Administration) and NCAs (National Competent Authorities) regarding device safety data

RECENT PROJECTS

• Medical Monitor in a large global trial with more than 1100 subjects enrolled, providing medical oversight for Sponsor and sites
• Oversees a group of safety associates who perform safety responsibilities for Sponsors on 100+ studies

PUBLICATIONS

• Acknowledged in Torsello G, Bertoglio L, Kellersmann R, et al. One-year results of the INSIGHT study on endovascular treatment of abdominal aortic aneurysms. J Vasc Surg. 2022;75(6):1904-1911.e3. doi:10.1016/j.jvs.2021.12.066