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eC-SSRS Solution from ERT Facilitates Compliance with New FDA Guidance on Suicidality Assessment in Clinical Trials
Date:1/5/2011

PHILADELPHIA, Jan. 5, 2011 /PRNewswire/ -- ERT (Nasdaq: ERES  - News), a global provider of technology and services to the pharmaceutical, biotechnology and medical device industries, announced that its eC-SSRS (Electronic Columbia Suicide Severity Rating Scale) solution facilitates compliance with the newly introduced Food and Drug Administration (FDA) guidance document entitled "Suicidality: Prospective Assessment of Occurrence in Clinical Trials."  A copy of this guidance can be downloaded from www.ert.com.

The recently released FDA guidance document is intended to assist sponsors in assessing the occurrence of treatment-related suicidality in clinical trials or drug and biological products. The guidance highlights the increasingly recognized importance of suicidality assessment in psychiatric and non-psychiatric drug trials and provides general principles for how best to achieve effective assessment during the drug development process. The document highlights the Columbia Suicide Severity Rating Scale (C-SSRS), which comprises a detailed interview as an approved assessment instrument. The guidance intends to serve as a focus for continued discussions among the FDA, pharmaceutical sponsors, the academic community and the public.

ERT's eC-SSRS is an electronic self-rated version of the C-SSRS, which was developed in collaboration with the scale authors and provides a cost-effective method of proactively monitoring suicidality for trial sponsors. The solution was designed in anticipation of the FDA recommendations outlined in the newly released guidance document. Using interactive voice-response technology validated against the C-SSRS, the eC-SSRS is a fully structured interview providing standardized questions, relevant follow-up questions, error-handling routines a
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