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Medical devices

A field with new needs

Medical device manufacturers need to have clinical data to back up their regulatory filings - especially for market access and as soon as the CE mark has been granted.

  • The authorities may require efficacy data that proves the clinical benefit for the patient as part of a reimbursement request – particularly in France.
  • The French authorities often require "real-life" post-marketing studies of device use after the CE mark has been awarded.

Axonal provides medical device manufacturers with project support

Our job is to understand the needs and constraints of a fast-changing, heterogeneous sector with specific characteristics.

We have a high level of expertise in healthcare product evaluation and can support medical device manufacturers from the study design stage through to the production of a report for the healthcare authorities.

 
We can manage the following projects (in full or in part):

  • upstream studies in which a demonstration of clinical benefit is useful for the CE mark application.
  • the clinical efficacy studies required for reimbursement in France.
  • studies that are funded by the French Ministry of Health’s STIC programme.
  • obligatorily non-interventional, post-marketing studies requested by the French authorities.

Our services range from consultancy (through our holding company Acuitude) and project set-up support through to full-service study design, implementation and management.

We also provide our know-how and our expertise to guide you through the regulatory process.

Our experience

 Axonal is used to fully managing this type of study:

  • with an industrial sponsor.
  • sponsored by one or more learned societies.
  • post-marketing studies of innovative medical devices, when the involvement of several industrial sponsors and learned societies has been requested by the regulatory authorities.

Axonal

An experienced partner for medical device manufacturers


A CRO with the in-house experience and skills needed to meet the specific requirements of the medical device sector

Clinical studies for reimbursement requests

Post-marketing studies requested by the French authorities