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Global biotech gains visibility into treatment-related risk of SIB

Clario’s exclusive patient-reported eC-SSRS rapidly detected suicidal ideation and behavior (SIB)

Situation

  • Sponsors/CROs need the ability to detect possible SIB
  • Regulators recommend or require SIB assessments with certain therapies
  • In this trial, SIB events occurred. The FDA required the PI to add prospective suicidal risk assessments to the study

Clario’s solution

  • Biotech chose Clario’s patient-reported eC-SSRS solution
  • Built-in real-time alerts notify site teams of any positive SIB results
  • Solution enables access to intra-study SIB analyses/trends

Impact

  • Patient-reporting led to more honest and accurate SIB data
  • Sponsor identified at-risk patients more quickly and accurately
  • Need for rater training and clinician interviews drastically decreased
  • Trial terminated early, potentially saving further lives

Improve patient safety, study timelines and data quality with Clario’s patient-reported SIB assessment