Experience

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The industry and regulatory guidelines are constantly changing. The crisis in the United States and now in the European Union has reversed much of the momentum and progress of medical innovation. As a result, clinical trial sponsors are searching for ways to lower costs and accelerate the clinical research element of drug or device development process.

Meditrial’s specialized expertise is the foundation for expediting the approval process. We address new industry challenges by participating in the working groups and taskforces for regulation development. Working closely with Regulatory Authorities, we can advise our clients the appropriate, adequate and sufficient path to success for phase I-IV studies as well as investigator-driven trials and commercial registries.

Meditrial had a successful track record of partnership to companies conducting medical device trials in Italy. The principals of the company, working closely with the Ministry of Health in Rome, provided a unique inside track to approval for non CE marked devices.