invivodata’s PRO Consulting Announces Collaboration With Dainippon Sumitomo Pharma America

PITTSBURGH — Sept. 19, 2007 — invivodata® inc., the industry leader in electronic patient reported outcomes (ePRO) solutions for global clinical research, today announced that its PRO Consulting® division has successfully completed the first collaboration with Dainippon Sumitomo Pharma America (DSPA) Inc., which required the evaluation of patient reported outcomes (PRO) instruments for measuring diabetic neuropathy symptoms.

DSPA elected to work with PRO Consulting on its diabetic neuropathy program shortly after the Food and Drug Administration released its draft guidance on using PRO measures in clinical trials last year. In this engagement, PRO Consulting is delivering a range of PRO measurement strategy and development services, in addition to a critical review of the program’s endpoints.

“We are very pleased with the results of our collaboration with PRO Consulting on the assessment strategy for our diabetic neuropathy program,” said Betsy Williams, Ph.D., clinical science and strategy head at DSPA. “The scientific and regulatory experts at PRO Consulting have proved to be a valuable resource, and we look forward to continuing our productive partnership.”

“It is always a pleasure to partner with pharmaceutical companies like DSPA that share our passion and high expectations for clinical trial data quality and integrity,” said Jean Paty, Ph.D., chief scientist and regulatory advisor at PRO Consulting.

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.

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 180 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.

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