Perceptive Informatics, the industry’s leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), today announced that it has entered into a license agreement with the EuroQoL Group. The license allows Perceptive to provide EQ-5D, a standardized instrument to measure health-related quality of life outcomes, through its Electronic Patient Reported Outcomes (ePRO) solution in an Interactive Voice Response (IVR) format. Perceptive Informatics is among the first organizations in the industry to offer the EQ-5D instrument in an ePRO-IVR format.
The agreement provides clinical study sponsors the ability to collect health-related quality of life patient reported outcomes data via the telephone, using Perceptive’s ePRO solution in an IVR format. With 83 official language versions of EQ-5D, the instrument can be used in a wide array of geographies for global clinical programs. EQ-5D is a non-disease specific instrument, making it applicable to a wide range of health conditions and treatments. The instrument allows for easy completion of required data by study participants. It provides a descriptive profile and a single index value for a particular health status.
“The use of electronic patient reported outcomes in clinical trials has grown rapidly, especially as ePRO data, which has been increasingly accepted by regulators, has expanded beyond efficacy data to include safety, inclusion/exclusion, and medication compliance data. As sponsors are now using ePRO for major therapeutic areas across phases of trials, our goal is to offer more value to clients in this important component of an overall eClinical platform,” said Steve Kent, President of Perceptive Informatics. “We are pleased to incorporate EQ-5D into our ePRO solution, working with the EuroQoL Group to provide biopharmaceutical companies with this well-respected, widely used instrument and additional level of standardization.”
“I believe that the availability of an IVR version of the EQ-5D is a significant breakthrough for the biopharmaceutical industry. As one of the most widely used standardized measures of health status in the world today, there are clear advantages to collecting EQ-5D data electronically. I expect that study sponsors, clinical researchers, and patients will be well served by this agreement between the EuroQoL Group and Perceptive since the IVR format provides a highly efficient option for EQ-5D data collection and database creation,” said Stephen Joel Coons, Ph.D., Member of the EuroQoL Group and Professor of Pharmacy and Public Health at The University of Arizona.
Perceptive’s ePRO solution in an IVR format offers an intuitive interface for capturing patient reported data, ranging from diaries and validated instruments, such as health-related quality of life questionnaires, to complex clinical assessments. Patients can use the Perceptive ePRO system by dialing a toll-free number where they access an application delivered in their own language. Applications are designed to facilitate rapid progression through questions, and responses can be entered easily by using a telephone key pad. Study sponsors and investigator sites can access ePRO data and diary compliance metrics in real time via an online web reporting capability. The ePRO solution has a rigorous clinical, linguistic, and systems validation in place.
About Perceptive Informatics
Perceptive Informatics, a subsidiary of PAREXEL, is the industry’s leading eClinical solutions provider. Perceptive Informatics offers unprecedented access to innovative eClinical technologies and resources, providing clinical trial sponsors, CROs, and other service providers with the benefits of an extensive line of products and services throughout the entire clinical development lifecycle. In August, 2008 Perceptive was joined with ClinPhone plc, and the newly combined organization offers eClinical software and services that increase the e