Refining Patient Reported Outcomes
- May 22, 2008
Event Highlights 2008 ePROficiency™ Educational Initiative
PITTSBURGH — May 22, 2008 — invivodata inc., the industry leader in electronic patient reported outcomes (ePRO) solutions and services for global clinical research, today announced the successful completion of its ePRO Conference 2008 in Boca Raton, Fla. Attendees participated in balanced discussions on the latest technologies, regulatory guidelines, success stories and industry trends in ePRO.
“The invivodata conference proved to be an excellent source of information on current PRO industry standards,” said conference attendee Diane Mizerak, manager of data management at Medarex Inc. “A strong point of the conference was its emphasis on the practical application of the working principles of PRO and ePRO in clinical research.”
During the two-day event, conference attendees from more than 30 international biopharmaceutical companies engaged in discussions about the advancing role of ePRO in new drug development. Representatives from companies including AstraZeneca PLC, Cypress Bioscience Inc. and Dainippon Sumitomo Pharma America Inc. presented real-world ePRO case studies and led discussions about global ePRO best practices. invivodata partner Medidata Solutions shared insight into ePRO data integration and recently announced partner ClinPhone Plc led a discussion on interactive voice response system (IVRS) ePRO. Representatives from Suncoast Clinical Research provided the site perspective and considerations when designing an ePRO data capture strategy.
Topics pertaining to the FDA’s Draft Guidance on PROs in Clinical Research were central to the event. Key regulatory presentations such as “Evolving FDA Expectations for PRO,” delivered by a former FDA official, and “PRO Endpoint Model Development,” delivered by scientists from invivodata’s consulting division, PRO Consulting®, provided information on the evolving thinking surrounding PROs in clinical development.
“The interest generated by the ePRO conference matches the increasing interest we are seeing in our PRO Measurement Strategy and Development Services,” said Dr. Jean Paty, chief scientist and regulatory advisor at PRO Consulting. “Considering the growing interest in PROs for clinical research and its regulatory implications, it’s no surprise that so many trial sponsors are eager to learn more about the latest PRO strategies and trends.”
“This conference marks the cornerstone of our ongoing educational initiative, ePROficiency 2008, which is designed to answer many of the questions that clinical trial sponsors have about effectively using ePRO in clinical research,” said Tom Henson, vice president of marketing at invivodata. “We’re extremely pleased with the positive responses we have received from so many conference attendees and hope they all left the conference with the information, knowledge and vision needed to accelerate their PRO strategies and improve their clinical research results.”
About invivodata inc.
invivodata combines behavioral science, information technology and clinical expertise to capture clinical trial data of the highest integrity directly from patients. invivodata’s electronic Patient Reported Outcomes (ePRO) system delivers high-quality patient self-reported data by driving patient compliance with the protocol and eliminating recall biases that plague self-report studies. The invivodata solution, which includes DiaryPRO for real-time PRO data collection and SitePRO for site-based PRO data collection, provides access to study data, giving researchers and sponsors visibility into study progress and improving trial efficiencies. invivodata’s solution has been used in more than 200 trials and is the industry-leading eDiary 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 are 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.
