Pittsburgh, PA (PRWEB) May 08, 2012
invivodata inc. ® the industry leader in reliable electronic solutions and strategic consulting services for successful Clinical Outcome Assessment (COA) data collection in global clinical research, today announced that it has been chosen to deliver regulatory consulting services for a Phase III trial that UCB Pharma is conducting in the development of a unique biopharmaceutical product to treat Rheumatoid Arthritis (RA).
UCB is adhering to recent statements issued by the U.S. Food and Drug Administration (FDA) indicating that researchers need to ensure all measurements and outcomes reflect what is actually happening with the patient (October 2011.) Specifically, instruments based upon a clinician’s evaluation of a patient (ClinROs), and measures taken by an observer (ObsROs), like a mother reporting about her child, are subject to the same requirements for reliability and validity as Patient Reported Outcomes (PROs), as delineated in the PRO Guidance (2010).
UCB’s trial protocol includes the Assessment of Joint Tenderness/Pain and Swelling (TSJ/C), a commonly used ClinRO instrument which clinicians use to document tenderness/pain and swelling during physical examination of a patient. UCB is migrating or moving the TSJ/C from the traditional paper-based administration to an electronic tablet, invivodata’s SITEpro®.
Consistent with FDA recommendations, UCB has contracted with invivodata to demonstrate that the use of an electronic tablet will not affect how clinicians interpret and use the TSJ/C instrument. invivodata’s scientists and regulatory experts will conduct cognitive interviews of clinicians to establish that electronic administration of the TSJ/C is equivalent to traditional, paper-and-pencil administration.
“Since electronic COA (eCOA) data will be the basis of our labeling claims, we needed a partner with not only technological expertise, but one who fully understands the evolving changes in US and European regulations,” said Geoffroy Coteur, Sr Health Outcomes Manager, at UCB. “We chose to work with invivodata based on their unique, integrated approach to developing, implementing, and justifying effective COA strategies. We are confident that their scientific and regulatory expertise, as well as their proven experience in conducting international trials makes them the best suited to help us meet our development objectives.”
“We are pleased to have been selected to perform these important pre-trial tasks that ensure UCB can have trust and confidence in this critical data,” said Dr. Jean Paty, invivodata Chief Scientist and Regulatory Officer. “To our knowledge, this is the first example of a ClinRO instrument going through a regulatory-driven migration process. We applaud UCB for their pioneering efforts to ensure all of their COA instruments meet the regulatory standard of well defined and reliable instruments.”
For more information on invivodata’s consulting services and eSolutions for effective COA data capture, visit http://www.invivodata.com.
invivodata is the only fully-integrated Clinical Outcomes Assessments (COA) company delivering regulatory-proven strategic consulting and practical electronic solutions to biopharmaceutical companies who depend upon patient-centered research. From reliable and scientifically sound consulting that helps research teams effectively develop, execute, and document COA strategies to electronically collecting COA data in global clinical development programs, invivodata helps its customers strategically use patient, clinician, and observer reported outcomes data (PROs, ClinROs & ObsROs) to support labeling claims, enhance reimbursement strategies, and meet other clinical program objectives. Through partnerships with leading CROs and eClinical technology providers, invivodata seamlessly integrates into the clinical trial ecosystem, helping to minimize operational risk and maximize efficiencies. invivodata’s electronic solutions and strategic consulting services have been used in over 600 clinical programs and are built upon the industry-leading ePRO system in delivering primary efficacy data for global 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, CA., USA. For more information, visit http://www.invivodata.com.