Case Study: Global Biotech Company achieves faster SIB detection and improved patient safety with Clario’s patient-reported eC-SSRS

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

Global Biotech Company faced an urgent safety and regulatory challenge after treatment-related suicidal ideation and behavior (SIB) events occurred in a trial and the FDA required prospective suicidal risk assessments. To address this, the sponsor selected Clario’s patient-reported eC-SSRS solution to detect possible SIB and comply with regulator expectations.

Clario deployed its patient-reported eC-SSRS with built-in real-time alerts and intra-study SIB analytics, notifying site teams immediately of positive results. The Clario solution produced more honest and accurate SIB data, enabled faster and more accurate identification of at‑risk patients, drastically reduced the need for rater training and clinician interviews, and supported early trial termination—potentially preventing further harm.