Needs in clinical investigations increased depending on the medical device CE mark regulatory status based on the European directive 93/42/EC – 2007/47/EC amending and the reimbursement access both require a solid argument based on clinical evidence and high proof level clinical study. Companies often minimize this step, which become quickly a handicap for the launch of the product.
AD-DM Consulting supports your market access and reimbursement projects, with the:
– Assessment and expertise of the clinical data available based on the HTA guidelines
– Literature review and monitoring
– Design and management of clinical trials
– Post-registration studies, post market studies, register and RCT
– Writing, proofreading and submission of the study protocol and study report
– Writing articles for scientific publication