PHILADELPHIA, June 12 /PRNewswire-FirstCall/ -- eResearchTechnology, Inc. , a leading provider of technology and services to the pharmaceutical, biotechnology and medical device industries, announced today that it is launching a new line of business focused on electronic patient reported outcomes (ePRO). This business will initially concentrate on the central nervous system (CNS) therapeutic area. The Company has entered into a long-term strategic relationship with Healthcare Technology Systems, Inc. (HTS), a leading authority in the research, development and validation of computer administered clinical rating instruments.
The strategic relationship includes the exclusive licensing (subject to one pre-existing license agreement) of 57 interactive voice response (IVR) cognitive function assessments offered by HTS, along with HTS’ IVR system and five-year consulting agreements with Drs. John Greist, James (Jeff) Jefferson, and David Katzelnick -- pioneers in the electronic assessment of patient outcomes for new therapies in CNS diseases. As part of its relationship with HTS, eRT will have rights to future products developed by HTS for use in Phase I-IV clinical trials and in other areas of clinical research. IVR assessments offer several advantages over traditional paper methods. Using IVR, assessments are standardized and all questions are asked and scored by direct automated methods with patients at clinical trial sites or their homes. Additionally, IVR assessments perform error checking during interviews and offer immediate data storage and may enhance the accuracy and timeliness of patient data entry and reduce costs.
“The strategic relationship with the HTS physicians furthers eRT’s medical and scientific knowledge in the CNS area,” said Dr. Jeffrey Litwin, Chief Medical Officer of eRT. “There is a known relationship between psychotropic drugs and cardiac safety, and the addition of these new products and services will further our ability to work with our sponsors to enhance the safety of new drugs in this area.”
“The strategic relationship with HTS opens up a new market for eRT, while leveraging our existing products and services,” commented Dr. Michael McKelvey, President and CEO of eRT. “The access to Drs. Greist, Jefferson, and Katzelnick will further our key CNS medical and scientific expertise and add to the value of our consultative services.”
“The addition of the products and services from HTS will allow us to leverage our market-leading position in the cardiac safety core lab business to other areas of drug safety,” added Dr. McKelvey. “We believe that the use of electronic patient reported outcomes will be a growing area over the next few years, and will be a key way to help assess the safety of new drugs and the long-term safety profile of older medications. In addition, electronic patient reported outcomes can be used for reducing patient withdrawal rates from trials, assessing quality of life, analyzing the impacts of drug discontinuation on a daily basis, and evaluating the long-term efficacy and safety of drugs (Phase IV or post-marketing surveillance trials). We believe that there will be a continued focus on the long-term safety profile of drugs, and that the addition of these products and services from HTS will help in that effort.”
Dr. Greist commented, “eRT and HTS were both founded by physicians, and each company is rooted in both clinical research and technical expertise. The union of eRT and HTS emphasizes the importance both organizations place on excellence in centralized ePRO products, including IVR assessments. HTS will continue its careful work to establish the scientific qualities of our IVR assessments. eRT has a longstanding reputation for technical accomplishment and excellent customer service which are hallmarks of HTS as well. Jeff Jefferson, David Katzelnick and I are delighted that eRT will now be providing HTS IVR assessments.”
Dr. McKelvey concluded, “The capabilities of HTS fit very well with our business model that is built around our belief that the centralized collection and interpretation of digital clinical trial information allows for higher quality analysis of the safety profile of new drugs. The use of IVR assessments in the centralized collection of electronic patient reported outcomes is very similar to the centralized collection of digital ECG data in our cardiac safety business and the centralized collection of clinical trial data in our eClinical business. Our strategic alliance with HTS is a unique opportunity that allows us to leverage many aspects of our business model in the ePRO area.”
The Company does not expect this new strategic relationship to have a material impact on its financial results in 2007.
Based in Philadelphia, PA, eResearchTechnology, Inc. (http://www.eRT.com) is a provider of technology and services to the pharmaceutical, biotechnology and medical device industries on a global basis. The Company is a market leader in providing centralized core-diagnostic electrocardiographic (ECG) technology and services to evaluate cardiac safety in clinical development. The Company is also a leader in providing technology and services to streamline the clinical trials process by enabling its customers to automate the collection, analysis, and distribution of clinical data in all phases of clinical development.
Healthcare Technology Systems, Inc. (HTS), of Madison Wisconsin (http://www.healthtechsys.com), is the culmination of direct patient-computer interviewing research begun more than 30 years ago at the University of Wisconsin. Anchored in clinical excellence in internal medicine and psychiatry, HTS computer interviews evolved through numerous hardware and software applications to emerge as clinically validated ePRO IVR assessments. Because the technological sophistication of clinical IVR systems is made transparent by user familiarity with ubiquitous touch-tone telephones, the versatile IVR tool is an ideal medium for centralized data collection.
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, 2007 financial guidance and market developments and trends, 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, 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: Richard Baron Brett Maas eResearchTechnology, Inc. Hayden Communications 215-282-5566 646-536-7331
eResearchTechnology, Inc.
CONTACT: Richard Baron, eResearchTechnology, Inc., +1-215-282-5566, orBrett Maas, Hayden Communications, +1-646-536-7331
Web site: http://www.eRT.com/
