Armêl Plaine, PhD, brings over 14 years of expertise in clinical investigations for medical devices, specializing in high-risk devices across various clinical development stages, including First-in-Man, Exploratory, Confirmatory, and Observational Studies.
After earning her doctorate in microbiology, she joined MedPass International, a European CRO focused on medical devices, where she advanced through roles as a Clinical Research Associate, Study Manager, and Head of the Clinical Regulatory Department. Armêl’s experience spans complex regulatory environments, such as Early Feasibility Studies and Randomized Controlled Trials (RCTs) under FDA regulations, and involves challenging scenarios like sham controls, emergency patient inclusion, and devices with drug or animal-origin components. Her comprehensive knowledge of clinical operations, from start-up to execution, makes her a leader in the field.