Mediolanum Cardio Research
            
        MCR has a consolidated experience and expertise to plan, coordinate and publish research trials involving
        medical devices. MCR staff also has experience in phase I-IV clinical trials and no-profit studies


  • TRIAL DESIGN
    Protocol Development
    Protocol Review
    Case Report Form Preparation
    Case Report Form Review

  • IDAS E-CRF
    Compliance with FDA 21 CFR part 11.
    Compatible with main web browsers
      (IE, Firefox, Chrome, Safari and Opera).
    On-line randomization.
    On-line control of data plausibility and consistency.
    Automatic query generation.
    Graphic reports and descriptive statistics.
    Audit Trail: tracking all user operations.
    Secure transmission using SSL 256-bit encryption.
    Hosting server in a secure web farm under 7x24 monitoring.
    Redundant hardware and backup.

  • CENTRAL COORDINATION
    Project Management
    Centers Recruitment
    Organization of Investigator Meetings
    Organization of study files for Investigators
    Monthly Reports and Newsletters
    Study Committees

  • REGULATORY ASSISTANCE
    Ministry of Health and
    Ethics Committees submission
    Safety Reporting

  • SITE MANAGEMENT
    Feasibility
    Site selection visits
    Site initiation visits
    Site Monitoring
    Close Up visits

  • DATA MANAGEMENT and STATISTICS
    Design Database
    Perform Single Data Entry
    Perform Double Data Entry
    Data Monitoring and Auditing
    Queries Generation

    Database lock
    Randomization list
    Sample size calculation
    Interim and Final Statistical Analysis

  • CORE LAB
    Quantitative Coronary Angiography Analysis
    IVUS Analysis
    ECG Analysis

  • REPORTING
    Final Report
    Statistical Report
    Final manuscript publication