invivodata Introduces a New Division, PRO Consulting

April 4, 2005

Applied Clinical Trials

Experts to Provide Critical Insight Into Effective Patient Reported Outcomes Measurement

Experts to Provide Critical Insight Into Effective Patient Reported Outcomes Measurement


PITTSBURGH -- April 4, 2005 -- invivodata inc., the industry leader in electronic patient reported outcomes (PRO) solutions for clinical research, today launched a new division, PRO Consulting. As a response to demand from trial sponsors, PRO Consulting provides greater access to leading scientific expertise to refine sponsors' approach to PRO-based research methods.

PRO Consulting provides consulting services to clinical researchers who make decisions about how to use PRO data to support their clinical trial objectives. Its team of international scientific experts will help clients choose the right PRO instrument, construct the correct sampling strategy to test their trial's endpoints, and plan validation procedures for PRO measures.

"The need for consulting services that take a scientific approach to applying PRO data to support drug and medical device development programs has never been greater," said Michael Hufford, Ph.D., president of PRO Consulting and vice president of scientific affairs at invivodata. "As the importance of collecting PRO data in clinical trials grows and the Food and Drug Administration's (FDA) interest in PRO data-capture methods heightens, clinical trial sponsors need to be confident that their PRO data will provide the best test possible of their treatment, while withstanding the scientific scrutiny of regulators."

With scientific expertise in psychometrics, research design, psychology and neurosciences, as well as extensive experience working with the FDA and other regulatory bodies, the PRO Consulting team is well qualified to help clinical researchers make the right decisions when it comes to collecting PRO data in clinical trials.

The PRO Consulting team has more than 75 collective years' experience capturing and reporting PRO data to support more than 200 drug and medical device development programs worldwide. Team members also participate in scientific advisory boards for a variety of biotechnology and pharmaceutical companies. The breadth of their experience includes work with in-clinic interviews, quality of life measures and momentary reports from patients using a wide variety of reporting platforms, including paper, interactive voice recognition systems and electronic methods.

In addition to Dr. Hufford, the PRO Consulting team comprises Brian Tiplady, Ph.D., a senior clinical scientist and a leader in the use of technology in research, with more than 27 years of experience applying innovative research methods; Saul Shiffman, Ph.D., professor of psychology (clinical and health psychology) at the University of Pittsburgh, and a world-renowned pioneer in PRO research methods; and Arthur Stone, Ph.D., professor and vice chair of the Psychiatry Department and director of the Applied Behavioral Medicine Research Institute at the State University of New York at Stony Brook, and an industry-recognized expert in patient data collection methods.

More information can be found at http://www.patientreported.com.

About invivodata inc.
invivodata (http://www.invivodata.com) 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 (PRO) 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 100 trials involving over 35,000 patients. It has also collected nearly 50 million patient-initiated records, and is the only eDiary system that has delivered the primary efficacy data for an FDA drug approval. 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.

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