Michael Federico, Vice President, ePRO, comments, "The release of the FDA document highlights the growing focus on treatment-related suicidality and the need to develop an accurate and effective method for use in clinical trials to enhance effective patient-safety monitoring. Bearing in mind the concerns regarding the burdens placed on investigators, ERT has created the eC-SSRS, a validated representation of the interview version C-SSRS, which facilitates the ability to reliably and reproducibly assess suicidality and comply with FDA guidance."
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About ERTBased in Philadelphia, PA, eResearchTechnology, Inc. (www.ert.com) is a global provider of technology and services to the pharmaceutical, biotechnology and medical device industries. The Company is a market leader in providing centralized core-diagnostic electrocardiographic (ECG) technology and services to evaluate cardiac safety in clinical development. It is also a leading provider of centralized respiratory technology and services to evaluate pulmonary function efficacy and safety in clinical development. Sponsors can further use the Company's solutions to streamline the clinical trials process by automating the collection, analysis, and distribution of ePRO clinical data
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