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Strategic KRIs

  • High Percentage of Subjects with Angina Pectoris Attacks
  • High Percentage of Subjects with Hyperglycaemic events
  • High Percentage of Subjects with Hypoglycaemic events
  • High Percentage of Subjects with NYHA stage deterioration
  • High Percentage of Subjects with PDs of grading
  • High Percentage of Subjects with PDs of staging
  • High Percentage of Subjects with PDs related to in/exclusion criteria (kri)
  • High Percentage of Subjects with poor quality ECGs
  • High Percentage of Treatment Interruption
  • High Percentage of Tumor Data Issues
  • High Percentage of Unblinding cases
  • High Rate of Automated Queries
  • High Rate of overall PDs
  • Inappropriate IP administration (dose/timing dispensing error)
  • Long Mean Time for Response to Queries
  • Overrecruitment
  • Radioactive Product Disposal Challenges
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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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