Mediolanum Cardio Research
            
    REGULATORY ASSISTANCE

    Ministry of Health and
    Ethics Committees submission
    Safety Reporting


  • A dedicated start-up unit is in place with full knowledge of regulations and local procedures.

  • MCR can manage regulatory submissions and negotiate financial contracts on Sponsor's behalf.

  • MCR has esperience in notification of clinical investigations with medical devices to the Ministry of Health.

  • MCR can support the sponsor for reporting of SUSARS to Health Authority and Ethis Committee as well as for distributing CIOMS to the investigators.
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