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Resources
Case Studies
Global biotech gains visibility into treatment-related risk of SIB
Global biotech gains visibility into treatment-related risk of SIB
Clario’s exclusive patient-reported eC-SSRS rapidly detected suicidal ideation and behavior (SIB)
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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