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ERT Announces AVERT™ for Suicide Risk Assessment in Clinical Development
Date:6/20/2013

Philadelphia, PA (PRWEB) June 20, 2013

ERT, a leading global solution provider for high-quality patient safety and efficacy endpoint data collection, today announced enhancements to AVERT™, its proven electronic suicide risk assessment system. Having already been used by over 32,000 clinical trial patients, AVERT is now available in both audio (phone) and visual (web/tablet) patient interfaces, offering greater flexibility to developers of new biopharmaceutical products.

Having captured over 100,000 assessments to date, AVERT is a proven and reliable tool for biopharmaceutical developers who need to assess for suicide risk during clinical development programs. Carl Gommoll, Sr. Director Clinical Development at Forest Research Institute stated, “It is critical for us to understand the complete safety profile of new drugs in development, especially if during the course of a trial, patients experience suicidal ideation and behaviors. By administering AVERT we feel we are taking the most comprehensive and effective approach to identify the emergence of suicidal ideation and behaviors in order to enhance patient safety, which is our highest priority.”

Biopharmaceutical developers face the risk of treatment-emergent suicidal ideation and behavior (SIB) occurrence among patients in clinical trials. As a result of this safety risk, in 2012 the U.S. FDA issued a revised Draft Guidance for Prospective Assessment of SIB in psychiatric and non-psychiatric trials. The guidance requires researchers in high-potential SIB risk areas to develop and follow study protocols that proactively assess SIB risk and enable proper behavioral health treatment for at-risk patients.

AVERT presents electronic administration of scientifically proven suicide risk assessment questionnaires. Its current application is delivered through an electronic patient self-rated version of the Columbia Suicide Severity Rating Scale (eC-SSRS), wh
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