PRO Consulting Announces Record Growth and Expanded Services

invivodata division meeting growing need for science-based PRO expertise

PITTSBURGH — Sept. 10, 2007 — invivodata ^® inc., the industry leader inelectronic patient reported outcomes (ePRO) solutions for global clinicalresearch, today announced that its PRO Consulting ^® division has closedits third consecutive record sales quarter. The growth has been fueled by PROConsulting’s expanding services that help clinical trial sponsors adhere to thedraft guidance issued by the Food and Drug Administration (FDA) on the use ofPRO measures in clinical trials.

Focused on helping sponsors collectpatient reported symptoms data that will be used to support product labelingclaims, PRO Consulting has become a trusted partner for biopharmaceuticalcompanies. “We’re pleased with the growth we have experienced in our PROConsulting division,” said Bob Young,president of PRO Consulting. “It’s gratifying that the services we offercontinue to meet the needs of clinical trial sponsors in meeting regulatoryexpectations as they develop and evaluate new medical treatments.”

PRO Consulting’s expert scientificstaff delivers valuable insights into optimal methods for collecting symptomsdata in clinical research. PRO Consulting added many new biotech andpharmaceutical industry clients in the past year. Projects undertaken by PROConsulting over the past nine months include PRO measurement strategy services,such as Endpoint Model Development and PRO Dossier Development, and ePRO migrationand validation services.

“We developed our services to help clinicaltrial sponsors optimize the PRO data that will help them determine theeffectiveness of new treatments,” said Jean Paty,Ph.D., chief scientist and regulatory advisor at PRO Consulting. “It isextremely rewarding to work with organizations that are committed to conductingclinical trials that optimally evaluate the safety and efficacy of treatmentoptions for patients.”

To help trial sponsors understand theimplications of the FDA Draft Guidance for migrating paper-based measures toelectronic methods, PRO Consulting is hosting a free educational webinar on Sept.13. Drs. Jean Paty and Chad Gwaltney will present “Migration of PRO Measuresfrom Paper to Electronic: Theoretical & Practical Perspectives.” Additionalinformation and registration is available at http://www.patientreported.com/webinar/ePRO_migration.html .

AboutPRO Consulting

PRO Consulting, a division of invivodata,inc., provides consulting services to help clinical research teams effectivelydevelop, execute, and document patient reported outcome (PRO) strategies tosupport their clinical research objectives. With specific expertise insymptoms-based outcomes, the PRO Consulting team has more than 140 years ofcumulative experience in psychometrics, PRO study design, migrating andvalidating electronic solutions to collect PRO data, and has extensiveexperience working with the FDA and other regulatory bodies. For more information please visit http://www.patientreported.com.

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