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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)

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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