PITTSBURGH, Jan. 12 /PRNewswire/ -- invivodata inc., the industry leader in patient reported outcomes (PRO) solutions and services for global clinical research, along with its scientific and regulatory consulting division, PRO Consulting® will conduct a complimentary Web Seminar on the Food and Drug Administration's (FDA) final Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.
The final PRO Guidance, which was published in December 2009, clearly articulates FDA's endorsement of the use of PROs to support medical product labeling and makes it very clear that the patient perspective is critical in the development and evaluation of PROs as well.
"For those of us who focus on the use of PRO data in clinical research, the publication of this final Guidance is a watershed event that underscores the significant shift we have seen to broader and more effective use of PRO data to support labeling for drug approval and in order to differentiate new products," said Dr. Jean Paty, invivodata co-founder and vice president of scientific, clinical, and regulatory affairs.
invivodata scientists have long contributed to and tracked the regulations and guidance surrounding patient data collection in clinical research. Since meeting with the FDA in 2001 to review the findings of a seminal study comparing paper and electronic diary methods, invivodata has provided feedback and participated in industry meetings that helped shape PRO expectations and guidance. Further, the PRO Consulting division has provided expertise to clinical researchers making key decisions about their PRO strategies for global clinical development programs.
The Web Seminar on the FDA final PRO Guidance is being conducted on Tuesday, January 19th at 11am EST. The discussion will provide analysis and insight into the FDA's final PRO Guidance to help biopharmaceutical and medical device researchers better understand how to effectively use PRO in their clinical development programs and what they should be doing differently moving forward in light of the guidance.
"The FDA is unusually prescriptive and detailed in the final PRO Guidance – this is a benefit to all of us considering PROs for medical product labeling," said Dr. Paty. "However, some clinical trial sponsors may have questions as to how it affects their research. By hosting this educational Web Seminar, we hope to provide answers to clinical researchers who are considering patient reported data in the development of their new pharmaceutical products."
For additional information on the final PRO Guidance and to register for the complimentary Web Seminar, visit www.invivodata.com/pro.
About invivodata inc.
invivodata combines behavioral science, information technology, and clinical research expertise to capture high quality clinical trial data directly from patients. invivodata's electronic Patient Reported Outcomes (ePRO) solutions, which are based on over 20 years of research, deliver reliable patient self-reported data by driving patient compliance with the protocol and eliminating recall biases that plague paper-based self-report data. invivodata's solutions include comprehensive trial-support services that facilitate the collection of ePRO data, web-based access to study data and operational reports that give researchers and sponsors visibility into study progress, and scientific and regulatory consulting on the use of PRO data in a regulated environment. invivodata's solution has been used in more than 275 clinical programs and is the industry-leading ePRO system in delivering primary efficacy data for FDA drug approvals. invivodata inc. is a privately held company with global headquarters in Pittsburgh, Pa., USA; its European headquarters is in London, England; and its technology development center is in Scotts Valley, Calif., USA. For more information visit www.invivodata.com.
About PRO Consulting
PRO Consulting, a division of invivodata, inc., provides consulting services to help clinical research teams effectively develop, execute, and document patient reported outcome (PRO) strategies to support their clinical research objectives. The PRO Consulting team has more than 140 years of cumulative experience in psychometrics, PRO study design, migrating and validating electronic solutions to collect PRO data, and has extensive experience working with the FDA and other regulatory bodies. For more information please visit http://www.patientreported.com.
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