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MedPass International is the leading full service Medical Device CRO in the EU assisting clients in the quick, efficient and cost effective clinical development and market access of emerging technologies. We have unparalleled regulatory and reimbursement expertise.
Despite the increasing regulatory and reimbursement challenges in the EU, Europe remains an attractive location for medical device clinical development, a springboard to access emerging markets in Asia Pacific and South America, and a more efficient location for conducting trials for US FDA.
Our start up clients benefit from a single, trusted vendor providing all clinical and regulatory activities from route to market roadmaps to first in man studies, clinical evaluations, CE marking, Post Market Clinical Follow-up, quality assurance, support during the post-market phase and Reimbursement for a seamless development program. Our multinational clients appreciate our flexibility, speed and willingness to work on an as needed basis, setting us apart from larger global CROs.
Since 1991, the company has participated in the successful development of hundreds of innovative technologies from the first fully functional cervical disc replacement in the late 1990's through dedicated interventional neuroradiology devices to treat stroke in early 2000 to CE marking of the first transcatheter aortic valve. Most recently, MedPass was regulatory consultant and CRO for the Clinical trial and CE marking of the first leadless cardiac pacemaker.
Tags: Phase 1, étude post-inscription, études de soins courants, études pharmaco-économiques, Phase 2, Phase 3, Phase 4, Economie de la Santé, Marquage CE, Rédaction médicale, Gestion de projet, Monitoring sur site, Monitoring central, Monitoring biologique, Data Management, Statistiques, Expertise Méthodologique, Audit, Gestion de la pharmacovigilance, Promoteur d'étude, e-CRF, Formation investigateurs, Dispositif Médical