WAYNE, Pennsylvania, February 28, 2012 /PRNewswire/ --
- Electronic patient-reported outcomes provide patient perspectives that are key to drug approval
Bracket, a division of United BioSource Corporation (UBC), announced today a new collaboration that will seek to improve the quality of patient reported outcomes, a crucial element in the drug development process. Bracket has joined the Electronic Patient-Reported Outcome (ePRO) Consortium, a program run by the Critical Path Institute (C-Path).
The ePRO Consortium is committed to advancing the quality, practicality, and acceptance of electronic data capture (EDC) methods used in clinical trials for PRO endpoint assessment. PROs provide the patients' perspectives of a medication or device during clinical trials and other clinical research studies. PRO endpoints include quality of life, symptoms, functioning, cognition and general health status.
Bracket will work with other members of the ePRO Consortium in a non-competitive, neutral environment to develop guidelines and advance the quality of electronic data collection methods for PROs. The ePRO Consortium, which was formed in 2011, will collaborate with C-Path's PRO Consortium, a group of pharmaceutical companies working to improve PRO measurement for high priority therapeutic areas to help migrate the new PRO measures developed by the PRO Consortium to the appropriate electronic data capture format. The ePRO Consortium will also develop guidance on methodological considerations for PRO instrument migration and adaptation.
"Incorporating the patient perspective in innovation and using new technology, like ePRO, to do so in a scalable manner is crucial to expanding and enhancing all aspects of electronic patient reported outcomes," said Dr. Robert Epstein, United BioSource president. "Partnering with the Critical Path Institute creates yet another venue for us to continue to advocate and innovate for the development of safe and effective drugs for patients."
C-Path is an independent non-profit institute created in 2005 by the University of Arizona and the U.S. Food and Drug Administration (FDA). Its neutral status allows C-Path to serve as an effective facilitator among scientists from the government, academia and the private sectors. C-Path has forged key partnerships, created collaborations and helped build new working relationships among federal regulators and the pharmaceutical industry. Led by C-Path, scientists from academia, biotechnology companies, the government and pharmaceutical industry are working together to develop innovative new testing methods that enable life-saving drugs, devices and biological products to reach patients faster and with greater safety.
Bracket is committed to leveraging the integration of science, technology and operational excellence to provide sponsors with unique, effective solutions to achieve greater precision and accurate outcomes in their clinical trials. Bracket utilizes a robust ePRO platform integrating IVRS, IWRS and CDR systems to efficiently collect complex data for global clinical trials. Bracket's user-friendly handheld solution is streamlining the way data are collected, transferred and managed to both simplify the process and improve data accuracy. Bracket collaborates with UBC researchers on scientific issues related to e-PROs, including strategic guidance on and scientific implementation of study design, instrument development and validation, regulatory requirements and labeling claims. For more information about Bracket, please go to: http://www.bracketglobal.com.
About United BioSource Corporation
United BioSource Corporation (UBC), a wholly owned subsidiary of Medco Health Solutions, Inc. (NYSE: MHS), is a global scientific and medical affairs organization that partners with life science companies to make medicine and medical products smarter for all stakeholders in the health care landscape. UBC helps deliver authoritative, real-world evidence to characterize product effectiveness, address safety risk, and demonstrate value. UBC brings together recognized scientific and industry experts, research operations professionals, and new technologies to provide innovative solutions across the product lifecycle. The company is headquartered in Chevy Chase, MD with offices in North and South America, Europe and Asia. For more information about UBC, visit http://www.unitedbiosource.com.
SOURCE Bracket Global