Overview

MedQIA offers real-time progression confirmation reads to support requests related to individual subject management and/or treatment crossover.

Process

  • Upon receipt of images, MedQIA readers review follow up timepoints against Screening scans to determine PD. Dual reads are completed within 5 business days of scan receipt.
    • In the pilot study for this real-time progression confirmation read paradigm:
      • The average turnaround time for completion of dual reads was 2.5 business days.
      • 88% of cases had dual reader agreement and the remaining cases were discordant.
  • For cases where the two primary reviewers are discordant on PD status, a consensus review is initiated.
  • Consensus review is performed by a reader who was not involved in the primary review. Consensus review is completed within 5 business days from dual read completion.
  • Progression Consensus Reports for each timepoint are uploaded to the secure MedQIA Web Portal within 1 business day of completion to be accessed by the Sponsor to confirm PD status (Yes vs. No).
  • MedQIA is also able to provide real-time progression confirmation reads using a single reader with no consensus read, depending on study design and/or regulatory guidance.