Fast-Tracking First-in-Human Trials, Anywhere
Accelerated Medtech and Biopharma Clinical Study Services
Medtech and Biopharma early-phase clinical trials require high experience, specialized knowledge, and flexibility. When you trust the outcome of your trial with us, you leverage a team of experts with a proven background of 15+ years.
Our sole focus is managing early-phase clinical studies through to success. bioaccess® has the expertise and customized approach you need to navigate your company towards an acquisition.
Our service capabilities include:
Feasibility and selection of research site and principal investigator (PI).
Review and feedback on study documents to comply with country requirements.
Trial set-up, start-up, and approval (institutional review board, ethics committee and health ministry).
Import permit and nationalization of investigational devices.
Study project management and monitoring.
Reporting (study status, inventory, serious and non-serious adverse events).