eRT Announces the Availability of the Suicidality Monitoring System(TM) For Clinical...

eRT Announces the Availability of the Suicidality Monitoring System(TM) For
Clinical Trials

PHILADELPHIA, June 19 /PRNewswire-FirstCall/ -- eResearchTechnology, Inc.
(eRT), (Nasdaq: ERES), a leading provider of centralized ECG and eClinical
technology, ePRO and other services to the pharmaceutical, biotechnology,
medical device and related industries, announced today the availability of the
EXPeRT(R) ePRO Suicidality Monitoring System(TM) (SMS). Suicidality screening
is required in a growing number of drug development programs as a part of
effective drug profiling and subject safety monitoring in clinical trials. The
SMS was developed to address regulatory concerns and reduce the cost and time
associated with clinician-administered suicidality assessments. It will also
improve the quality of suicidality assessments compared to those performed by
clinicians alone. SMS was developed in conjunction with Drs. John Greist,
Alan Gelenberg, James Mundt, David Katzelnick and Jeff Jefferson. It is the
most recent addition to a growing line of telephone-based assessments within
the EXPeRT(R) ePRO services offered by eRT.
SMS is a simple patient monitoring and alert tool. It enhances subject
comfort while generating critical information for site research staff and
investigators in evaluating suicidality risk factors. It is easily added to
any clinical trial. If a potential suicidality signal is detected for a
subject, the SMS promptly alerts the investigator site to permit more in-depth
clinical follow-up and evaluation.
Dr. John Greist, an eRT consultant with decades of experience and research
on computer interviewing, described some of the benefits of SMS: "SMS provides
a user-friendly telephone interface as a computer terminal to collect
sensitive suicidality data directly from trial subjects. Advantages of
Interactive Voice Response (IVR) technology are: constant availability;
reliable, consistent, and complete presentation of every question; electronic
recording of respondents' answers; documentation of the assessment completion;
and prompt feedback and reporting to the study sites. Patients are more
likely to disclose sensitive subject matter, including suicidality, in
computer interviews than they will to human interviewers. The SMS models the
ideal human interviewer, comprehensively and consistently covering every
relevant topic while efficiently branching around irrelevant questions. Sound
science requires standardization of measurement; the SMS provides a standard
of procedural reliability that surpasses the reliability of human
investigators performing such assessments."
"Just as the use of digital ECGs in assessing cardiac safety has become an
essential part of drug development, we believe that the use of SMS in
assessing suicidality will also become an integral part of the drug
development process," said Jeffrey S. Litwin, M.D., eRT's Chief Medical
Officer.
EXPeRT(R) ePRO was launched by eRT in conjunction with Healthcare
Technology Systems (HTS), a leading authority in the research, development and
validation of computer administered clinical rating instruments. It leverages
HTS' expertise and eRT's existing infrastructure and role as a leading
provider of clinical solutions to the pharmaceutical, biotechnology, medical
device and related industries. Electronic patient reported outcome (ePRO)
assessments are standardized, with all questions asked and scored by direct
automated methods from trial subjects at any location with telephone access.
Additionally, ePRO assessments provide subject response checking during
interviews, offer immediate data storage to prevent potential data loss, and
improve the accuracy and timeliness of subject data entry and increased
clinical study efficiencies.
About eResearchTechnology, Inc.
Philadelphia-based eResearchTechnology (http://www.eRT.com) delivers
technology-based products and services that enable pharmaceutical,
biotechnological and medical device companies to collect, interpret and
distribute cardiac safety and clinical data more efficiently. eRT is a market
leader in centralized electrocardiographic (ECG) services-a core diagnostic
capability-and a leading provider of technology and services that allow
customers to automate and streamline data-based components of clinical trials,
helping them bring new drugs to market faster.
Forward-looking statements
Statements included in this release may constitute forward-looking
statements within the meaning of the Private Securities Litigation Reform Act
of 1995. Such statements, including but not limited to 2008 financial
guidance, involve a number of risks and uncertainties such as the company's
ability to obtain new contracts and accurately estimate net revenues due to
uncertain regulatory guidance, variability in size, scope and duration of
projects, and internal issues at the sponsoring client, integration of
acquisitions, competitive factors, technological development, and market
demand. As a result, actual results may differ materially from any financial
outlooks stated herein. Further information on potential factors that could
affect the company's financial results can be found in the company's Reports
on Form 10-K and 10-Q filed 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.
SOURCE eResearchTechnology, Inc.

Greg Sadowski, Senior Vice-President, ePRO, eResearchTechnology, Inc.
+1-908-252-4999, gsadowski@ert.com