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Strategic KRIs

  • Adjudication committee members non-availability (General TA)
  • Delay in IP availability for Subject treatment
  • Discrepancy b/w Locals and Central Labs Data
  • Extended Hospital Stay compared to expectation (Complications)
  • High Number of Sites with Local Lab References Ranges Delay
  • High Percentage of Early Subject Deaths
  • High Percentage of Ejection Fraction is lower 40% (can be modified)
  • High Percentage of Failed ePRO Devices
  • High Percentage of High Risk Sites in a Study
  • High Percentage of Image interpretation issues (Differences)
  • High Percentage of Image interpretation issues (Quality)
  • High Percentage of IMP Supply Issues
  • High Percentage of Incorrect Subject Randomization
  • High Percentage of Med Device Malfunction
  • High Percentage of Med Device Malfunction
  • High Percentage of Medical Device interface performance Issues
  • High Percentage of Missing Forms (Pages)
  • High Percentage of Start-Up Delays
  • High Percentage of Subject Death
  • High Percentage of Subjects who can't switch from one formulation to another formulation
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Categories

  • Blinding
  • Cardiovascular Therapeutic Area
  • Data Collection Procedures
  • Diabetes Therapeutic Area
  • General Therapeutic Area
  • Golden KRIs
  • IMP supply chain
  • Medical Device Therapeutic Area
  • Oncology Therapeutic Area
  • Operational Complexity
  • Organizational Experience
  • Safety
  • Strategic KRIs
  • Study Complexity
  • Study Endpoints
  • Subject Population
  • Technology
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