PHILADELPHIA, June 19 eResearchTechnology, Inc.(eRT), (Nasdaq: ERES), a leading provider of centralized ECG and eClinicaltechnology, ePRO and other services to the pharmaceutical, biotechnology,medical device and related industries, announced today the availability of theEXPeRT(R) ePRO Suicidality Monitoring System(TM) (SMS). Suicidality screeningis required in a growing number of drug development programs as a part ofeffective drug profiling and subject safety monitoring in clinical trials. TheSMS was developed to address regulatory concerns and reduce the cost and timeassociated with clinician-administered suicidality assessments. It will alsoimprove the quality of suicidality assessments compared to those performed byclinicians alone. SMS was developed in conjunction with Drs. John Greist,Alan Gelenberg, James Mundt, David Katzelnick and Jeff Jefferson. It is themost recent addition to a growing line of telephone-based assessments withinthe EXPeRT(R) ePRO services offered by eRT.
SMS is a simple patient monitoring and alert tool. It enhances subjectcomfort while generating critical information for site research staff andinvestigators in evaluating suicidality risk factors. It is easily added toany clinical trial. If a potential suicidality signal is detected for asubject, the SMS promptly alerts the investigator site to permit more in-depthclinical follow-up and evaluation.
Dr. John Greist, an eRT consultant with decades of experience and researchon computer interviewing, described some of the benefits of SMS: "SMS providesa user-friendly telephone interface as a computer terminal to collectsensitive suicidality data directly from trial subjects. Advantages ofInteractive Voice Response (IVR) technology are: constant availability;reliable, consistent, and complete presentation of every question; electronicrecording of respondents' answers; documentation of the assessment completion;and prompt feedback and reporting to the study sites. Patients are morelikely to disclose sensitive subject matter, including suicidality, incomputer interviews than they will to human interviewers. The SMS models theideal human interviewer, comprehensively and consistently covering everyrelevant topic while efficiently branching around irrelevant questions. Soundscience requires standardization of measurement; the SMS provides a standardof procedural reliability that surpasses the reliability of humaninvestigators performing such assessments."
"Just as the use of digital ECGs in assessing cardiac safety has become anessential part of drug development, we believe that the use of SMS inassessing suicidality will also become an integral part of the drugdevelopment process," said Jeffrey S. Litwin, M.D., eRT's Chief MedicalOfficer.
EXPeRT(R) ePRO was launched by eRT in conjunction with HealthcareTechnology Systems (HTS), a leading authority in the research, development andvalidation of computer administered clinical rating instruments. It leveragesHTS' expertise and eRT's existing infrastructure and role as a leadingprovider of clinical solutions to the pharmaceutical, biotechnology, medicaldevice and related industries. Electronic patient reported outcome (ePRO)assessments are standardized, with all questions asked and scored by directautomated methods from trial subjects at any location with telephone access.Additionally, ePRO assessments provide subject response checking duringinterviews, offer immediate data storage to prevent potential data loss, andimprove the accuracy and timeliness of subject data entry and increasedclinical study efficiencies.
About eResearchTechnology, Inc.
Philadelphia-based eResearchTechnology (http://www.eRT.com) deliverstechnology-based products and services that enable pharmaceutical,biotechnological and medical device companies to collect, interpret anddistribute cardiac safety and clinical data more