An Award Winning Solution
Increased suicidality risk with novel compounds is a growing concern. That's why prospective suicidality monitoring is now a requirement in an increasing number of drug-development efforts to ensure effective drug-profiling and patient-safety monitoring.
ERT offers an electronic self-rated version of the Columbia Suicide Severity Rating Scale (C-SSRS) to facilitate compliance with regulatory requirements for prospective monitoring of suicidal ideation and behaviors. The validated eC-SSRS solution, developed in collaboration with the scale author, is a cost-effective method of prospectively monitoring for suicidality. It has been designed, in line with anticipated FDA requirements, to reliably and reproducibly assess suicidality in clinical trials; thereby, protecting patient safety while significantly reducing the burden on study sites.
eC-SSRS - Kelly Posner, Director of the CSRA at Columbia University, and primary author of the C-SSRS, comments:
"The FDA Division of Psychiatry Products has indicated that C-SSRS is an acceptable prospective suicidality monitoring assessment. As primary author of the Columbia-Suicide Severity Rating Scale (C-SSRS), I believe the eC-SSRS is a faithful and accurate representation of the interview version of C-SSRS and has been carefully designed to produce consistent outcomes."
Enhanced Technology to Screen, Monitor and Alert for Suicidality
- Delivers complete solution - coordinated with clinician efforts
- Screens and documents patient suicidality signals
- Enhances subject comfort and disclosure compared to human interviews
- Interprets patient-reported behaviors and symptoms
- Enhances subject comfort and disclosure compared to human interviews
- Notifies the investigator instantly by phone or e-mail, ensuring timely receipt of alerts
- Alerts multiple parties including sites, clinical research associates (CRAs), and safety monitors
Quick startup - it can be added to any trial
Implements best-practice guidelines, with anticipated guidance document
Using a coordinated eC-SSRS approach, compared to clinician-only methods can significantly reduce the cost of suicidality monitoring.
