“invivodata was able to deliver us the real-time data that we needed to develop an unbiased view into our patients’ pain experiences. This kind of data cannot be collected with paper diaries.”
Dr. Michael Gendreau
Chief Medical Officer, Cypress Bioscience
invivodata Announces Web Seminar Series
- September 02, 2008
invivodata Announces Web Seminar Series
Scientific and Regulatory Experts to Review Current US and European Regulatory Environments for Patient Reported Outcomes
invivodata inc., the industry leader in electronic patient reported outcomes (ePRO) solutions and services for global clinical research, today announced the continuation of its ePROficiency™ educational initiative with a new Web Seminar series. Scientists from invivodata and its consulting division, PRO Consulting® will deliver two educational programs on the effective use of Patient Reported Outcomes (PRO) data in the current U.S. and European regulatory environments.
On September 16, 2008, invivodata scientists will explore various elements of the U.S. Food and Drug Administration’s (FDA) Draft Guidance on PROs in Clinical Research by hosting “How Much do you know about the FDA Draft PRO Guidance?” Led by PRO Consulting scientist, Dr. Chad Gwaltney, this Web Seminar will provide answers to commonly asked PRO questions, including those pertaining to validation requirements, the cognitive debriefing process, and calculating a Minimally Important Difference.
The second part of the series will be held on October 28, 2008 when invivodata will host “ePRO Regulatory Environment in Europe”. In this Web Seminar, Dr. Jean Paty, invivodata’s senior vice president, scientific, quality, and regulatory affairs will lead a discussion on the factors that clinical trial sponsors should consider when running ePRO trials across Europe, with special focus on current trends related to PRO within the European Medicines Agency (EMEA).
“These Web Seminar programs are designed to help researchers make key decisions about their PRO strategy and instruments for clinical programs and individual trials,” said Tom Henson, invivodata vice president, marketing. “We’re pleased to offer this series as a component of ePROficiency™ 2008, which provides clinical trial sponsors with the latest regulatory, scientific and industry information on PROs in clinical research.”
Detailed information and registration for each complimentary Web Seminar can be found at www.invivodata.com.
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, and web-based access to study data and operational reports that give researchers and sponsors visibility into study progress and improve trial efficiencies. invivodata’s solution has been used in more than 200 trials 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.
