Medical Device Trials
As a SMO with a particular focus on the medical device industry, Clinical Research Ireland offers a range of customised services, which can be deployed on a stand-alone basis or as part of an integrated full-service solution, that support all phases of clinical trial development and testing for various technologies and therapeutic areas. Medical device clinical trials require various resources that many medical device companies and academic groups cannot support in house.
Our service offerings include protocol design, site sourcing and project management, to provide our clients with the necessary clinical data to support a regulatory pre-market submission, scientific publications, drive product adoption and market acceptance, support product reimbursement, or monitor post-market product use. We can advise on how best to measure the effectiveness of your medical device, in the most clinically meaningful way possible to support your product claims. Additionally, we recognise that clinical trial strategy is integral to successful commercialisation of a medical device. Our team of experts can advise on appropriate protocol designs that will meet medical device requirements and aid the marketing process in both the European Union and U.S.
All of our staff and clinical research collaborators involved in the conduct of medical device trials in sites managed by Clinical Research Ireland are certified in the International Organisation for Standardisation (ISO) 14155 as necessary to meet standards required by national and international regulatory bodies.