CQCSM Continuous Quality Control
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MedAvante offers CQC, our proprietary centralized monitoring and quality control service. In CQC the study instrument is administered and recorded locally at the investigative site by raters. The assessment and the raters are remotely monitored, evaluated and calibrated to MedAvante’s centralized expert trainer team.  Only MedAvante measures site ratings against a single uniform world-wide standard benchmark of clinical excellence.

    With CQC, Continuous Quality Control, sponsors get visibility and control of the quality of patients enrolled and quality of assessments during the study.  This allows sponsors to gain some of the benefits of MedAvante’s expert centralized raters and expertise (30,000 remote expert ratings administrations in Phase II and Phase III) while still working with their preferred sites to administer the assessments.

    How MedAvante CQC Works:

    1. Site-based raters digitally record all their subject interviews through provided laptop.
    2. All the recorded interviews and source documents are uploaded to MedAvante via the internet.
    3. Recorded Interviews and source documents are electronically tracked and automatically routed to a MedAvante expert trainer according to and algorithm agreed upon with the Sponsor.
    4. MedAvante expert trainer listens to the entire subject interview
      • Provides own score of interview scale: automated workflow program will not provide site's scores until MedAvante expert trainer enters their assessment scores.
      • Scores the site-based rater's clinical interviewing skills using the Rater Applied Performance Scale (RAPS).
    5. Provides Sponsor with the real-time Quality Scorecard & provides the site-based raters with calibrating feedback.
      • MedAvante expert trainers are calibrated to provide consistent feedback to all site raters to minimize rater variability.

     This rigorous process offers substantial benefits, including: 

    Visibility to Patient Quality and Study Assessments for:

     Enhanced Signal Detection

    Calibration of site-based raters to MedAvante centralized expert trainer cohort

    • MedAvante expert trainers are continuously calibrated to maintain > .90 ICCs on all scales – highest published reliability in industry.
    • MedAvante expert trainers are continuously tested to ensure site-based raters anywhere in the world receive consistent feedback , scoring or interviewing skills, from any MedAvante expert trainer

        Unique logistics scorecard – of real-time study-wide metrics
        • When and how many patients are screened per site
        • Screen fail rates by site and for entire study
        • Up-to-the-minute enrollment information for entire study
        Unique rater metrics produced – continuously by site/by rater:
        • Minimizes rater drift, ratings variability and remediates interview quality.
        • Alerts sponsor to discordance on assessment accuracy with MedAvante Centralized Expert Trainers – particularly important on enrollment decisions.
        • Baseline score distributions by site by visit.
        Proprietary Automated workflow programming
        • Tracks and automatically routes recordings for monitoring e.g. based on previous rater performance.
        • Tracks and ensures MedAvante Trainers are continuously monitored & calibrated.