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PHILADELPHIA, PA – July 10, 2013 –– ERT, a leading global solution provider for high-quality patient safety and efficacy endpoint data collection, today announced that it is authorized to provide validated, electronic versions of commonly used health-related Quality of Life (QoL) questionnaires on SITEpro® Tablet -- its patient data collection system for use at the investigative site. The questionnaires, developed by Professor Elizabeth Juniper, are considered the gold standard for measuring QoL among patients in clinical trials of medical products being developed for the treatment of asthma and rhinoconjunctivitis.
SITEpro enables biopharmaceutical companies to capture important Clinical Outcome Assessments (COAs) - including patient, clinician, and observer reported outcomes (PROs, ClinROs, and ObsROs) -- via an easy-to-use electronic tablet. Patients and site personnel use SITEpro during investigative site visits to respond to questionnaires about their health and quality of life as they participate in clinical trials of new medical products. The authorization will give biopharmaceutical companies confidence that SITEpro is an effective tool for measuring quality of life as they develop medical products for the treatment of asthma and rhinoconjunctivitis.
In order to receive authorization, the screen shots for SITEpro Tablet were formatted to be as similar as possible to the validated paper versions of the questionnaires. In addition, ERT successfully demonstrated that patients were able to use, understand, and complete all three questionnaires on both SITEpro Tablet 10” and SITEpro Tablet 12” data collection devices. The specific assessments that have been authorized for SITEpro Tablet administration include:
• Asthma Control Questionnaire (ACQ)
• The standardized version of the Asthma Quality of Life Questionnaire (AQLQ(S))
• The standardized version of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S))
“Evidence strongly suggests that that the most accurate method for capturing health status data is to have patients respond to our questionnaires during investigative site visits,” said Professor Juniper. “By formatting the screen shots to be as similar as possible to the original paper versions, and by checking the usability of the tablet versions in patients, the probability of obtaining valid data is high. Therefore, I am pleased to authorize SITEpro Tablet for capturing these important clinical outcomes.”
“We relied on Professor Juniper’s expertise as an industry-leading instrument developer and worked closely with her to ensure that patients completing the questionnaires on SITEpro would provide data of the highest quality and reliability,” said Bob Young, Chief Strategic Officer, ERT. “This authorization verifies that the scientific foundation upon which our solutions are built meets the high standards set by Professor Juniper. We look forward to continuing our relationship with her as we validate additional technologies for capturing important data from patients.”
For more information on SITEpro and ERT’s additional, proven solutions for accurate and reliable COA data collection, please visit www.ert.com/clinical-endpoints/outcomes-assessments/.
About ERT
ERT (www.ert.com) is a leading provider of high-quality patient safety and efficacy endpoint data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle. ERT delivers the most widely deployed solutions in centralized cardiac safety, respiratory services, suicide risk assessment and Clinical Outcome Assessments (COA) – which includes patient, clinician, and observer reported outcomes. By efficiently integrating these solutions through a system built upon a scientific and regulatory foundation, ERT collects, analyzes, and delivers safety and efficacy data critical to the approval, labeling, and reimbursement of pharmaceutical products. ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Japan, and Germany.
About Professor Elizabeth Juniper
Elizabeth F. Juniper, MCSP, MSc., Professor Emeritus, Department of Clinical Epidemiology and Biostatistics, McMaster University, Canada. Professor Juniper trained as a physiotherapist and later, while at the Royal Postgraduate Medical School, took a degree in Medical Physics and Physiological Measurement. In 1973, she emigrated to McMaster University in Canada where her primary interest was in asthma and rhinitis research. Over the next decade, she was first author of classic methods papers on the measurement of airway hyperresponsiveness and she designed, conducted and published a large number of clinical trials both in asthma and rhinoconjunctivitis. Following her further degree in clinical epidemiology and biostatistics, her interest turned to the development of methods to measure subjective health status. Her asthma and rhinitis quality of life questionnaires as well as her Asthma Control Questionnaire are now used throughout the world both in research and clinical practice.
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