Invivodata Certified To Deliver EXACT In COPD Trials

Main Category: Respiratory / Asthma
Also Included In: IT / Internet / E-mail;  Medical Devices / Diagnostics
Article Date: 24 Apr 2009 - 4:00 PDT

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invivodata inc., the industry leader in electronic Patient-Reported Outcomes (ePRO) solutions and services for global clinical research, announced that it has completed a certification program to provide the EXAcerbations of Chronic pulmonary disease Tool (EXACT) on its DiaryPRO(C) field-based ePRO system.

The EXACT is a Patient-Reported Outcome (PRO) measure for evaluating the frequency, severity, and duration of acute exacerbations of chronic obstructive pulmonary disease (COPD) and chronic bronchitis (AECB) in international clinical trials. Developed by United BioSource Corporation's (UBC) Center for Health Outcomes Research, with significant input from clinical and instrument development experts and involvement of the U.S. Food and Drug Administration (FDA), the EXACT is the industry's only standardized tool for measuring exacerbations of COPD.

"Being a certified provider of this unique tool enables us to offer our global customers a reliable and efficient means of implementing the EXACT in their clinical trials as they develop more effective COPD treatments," said Tom Henson, invivodata vice president of marketing.

COPD, which includes chronic bronchitis and emphysema, is a disease characterized by obstruction to airflow that interferes with normal breathing. COPD is the fourth leading cause of death in the world, and further increases in the prevalence and mortality of the disease are predicted in the coming decades. In the United States 11.4 million Americans are diagnosed with the disease with over 122,000 deaths each year. Clinical researchers have put significant effort into developing new COPD treatments, as evidenced by the 33% increase in clinical trials for new COPD medications since 2006.

"We are pleased to certify invivodata on the electronic delivery of the EXACT and to continue our work with them in assuring high quality data in all types of clinical studies in which the instrument is used," said Dr. Nancy Kline Leidy, senior vice president of scientific affairs for UBC and Principal Investigator of the EXACT-PRO Initiative. "We have found their e-diary device meets the needs of the EXACT and is ready for use in international trials."

Licensing agreements to use the EXACT are obtained directly from United BioSource Corporation.

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.

About United BioSource Corporation

United BioSource Corporation delivers science-based solutions to support the development and commercialization of pharmaceuticals, biotechnology, and medical devices. The company leverages a unique suite of scientific and strategic capabilities to demonstrate product effectiveness and safety, manage and minimize risk, document economic value, and secure appropriate third-party payment for prescription medicines and other medical technology. UBC's global operations are managed by research scientists and industry experts in offices throughout North America and Europe. The company is headquartered in Bethesda, Maryland.

Source: invivodata inc

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