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 and scoring
conventions. Helping to facilitate the FDA requirements, the
eC-SSRS solution enables timely identification of possible risks
and supplies rapid feedback to study sites for evaluation and
follow-up.
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."
For further information on ERT and its technology and services,
please email info@ert.com, call +1 215 972 0420 or visit
www.ert.com.
For further press information, please contact Fiona Robinson, The Scott Partnership, 1
Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA,
United Kingdom. Phone +44 1477
539539, Fax +44 1477 539540, email ert@scottpr.com.
About ERT
Based 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 using multi-mode technology in
all phases of clinical development as well as selected medical
devices for the clinical trials and healthcare industries.
Statements included in this release may constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements involve a
number of risks and uncertainties, which could cause actual results
to differ materially from those expressed or implied from such
statements. These risks and uncertainties include, without
limitation, the Company's ability to obtain new contracts,
variability in size, scope, and duration of projects, integration
of acquisitions, competitive factors, technological development,
market demand, and other factors described in the Company's filings
with the Securities and Exchange Commission. The Company
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events,
or otherwise.
Media
Contacts:
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Fiona Robinson
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John Blakeley
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The Scott
Partnership
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ERT
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Tel: +44 1477
539539
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+1 215 972 0420
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ert@scottpr.com
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jblakeley@ert.com
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SOURCE ERT