Key Risk Indicators (KRIs)

A Unique Combination of Statistical Analysis and Subjective Thresholds to Identify Study Risks

1
Site Performance

Obtain a prioritized view of your sites based on their performance.

2
Site Performance

See site performance based on your thresholds and relatively against other sites.

3
Review Trends

Review KRI trends and evaluate effectiveness of your corrective actions.

Hover over the toggles to discover the features.
UNCOVER SITES 'AT RISK'

CluePoints’ KRI Dashboard harnesses the power of statistical algorithms to provide a convenient way to monitor how sites are performing versus the metrics that are important to the trial. Sites are ranked and prioritized by those with most performance issues, thus illuminating the sites that are ‘at risk’.

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1
Site Performance

Obtain a prioritized view of your sites based on their performance.

2
Site Performance

See site performance based on your thresholds and relatively against other sites.

3
Review Trends

Review KRI trends and evaluate effectiveness of your corrective actions.

Hover over the toggles to discover the features.
  • Key Risk Indicators offer a prioritized, risk-based approach to monitoring trials, as advocated by the FDA and ICH.
  • Provides users with the power of an objective statistical analysis as well as subjective thresholds to trigger actions across key variables.
  • Choose from a pre-defined set of KRIs, or add KRIs specific to your own data points.
  • Each KRI comes with two results: Relative Score (how site is performing against peers) and Absolute Score( how site is performing against Tolerance Limits).
  • Drill down into patient data to interrogate the cause and effect, and select the relevant Patient Profiles to further interrogate the results.
  • Flag all potential issues and ensure successful corrective action using the inherent Issue Tracking Management System.

Just a few examples of the Key Risk Indicators some of our clients are using in their studies:

  • Non-Serious Adverse Events Rate:
    Rate of non-serious adverse events per patient visit.
  • Serious Adverse Event Rate:
    Rate of serious adverse events per patient visit.
  • Missed Assessment Rate:
    Proportion of expected patient assessments that were not conducted; i.e., “missed” (for identified assessments of interest)
  • Protocol Deviation Rate:
    Rate of protocol deviations per patient visit
  • Off Schedule Visit Rate:
    Rate of patient visits conducted outside of allowable schedule
  • eCRF Visit-to-Entry Cycle Time:
    Average cycle time from patient visit to eCRF entry
  • Auto-Query Rate:
    Rate of auto-queries generated per datapoint submitted
  • Query Response Cycle Time:
    Average cycle time from query generation to query response
  • Screen Failure Rate:
    Proportion of screen-failed patients to total screened patients
  • Early Termination Rate:
    Rate of early-terminated patients per patient visit

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