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