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ERT Offers a New Self-Rated Version of the C-SSRS, Facilitating Prospective Suicidality Monitoring
Date:3/15/2010

PHILADELPHIA, March 15 /PRNewswire-FirstCall/ -- ERT (Nasdaq: ERES), a leading provider of centralized services to global pharmaceutical, biotechnology and medical device companies, announces a pioneering 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 lead 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.

In recent years, there has been increased focus on treatment-emergent suicidality and the development of a reliable assessment method for use in clinical trials to enhance effective patient-safety monitoring. The FDA is developing guidance on regulatory requirements for suicidality monitoring. In light of concerns regarding the burdens placed on investigators, ERT, in collaboration with the scale authors, the Center for Suicide Risk Assessment (CSRA) and Healthcare Technology Systems, developed the eC-SSRS.  

Kelly Posner, Director of
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SOURCE ERT
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