Support for Pre-Clinical Activities and Clinical Trials

Our expertise in clinical research originates from the pharmaceutical sector and has since expanded to include medical devices.

Our team assists medical device and IVD manufacturers from the definition of the regulatory strategy to full support in setting up and conducting clinical investigations. This includes protocol preparation, interaction with Ethics Committees and Competent Authorities, monitoring of the entire clinical trial, data collection, final reporting, publication, and data sharing.

Do you require help or further information?

…

+39 0542 683803

Gap analysis of applicable standards

Characterization of substance-based devices

Real-world usability evaluation

Clinical investigation

PMCF clinical surveys

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