PHILADELPHIA, June 19 /PRNewswire-FirstCall/ -- eResearchTechnology, Inc. (eRT), , 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.
CONTACT: Greg Sadowski, Senior Vice-President, ePRO, eResearchTechnology,
Inc. +1-908-252-4999, gsadowski@ert.com
Web site: http://www.ert.com/
