PITTSBURGH, PA – December 13, 2010 –– invivodata inc.®, the industry leader in patient reported outcomes (PRO) solutions and services for global clinical research, along with its scientific and regulatory consulting division, PRO Consulting®, today announced the publication of the industry’s first comprehensive reference on electronic Patient Reported Outcomes (ePRO). Co-edited by PRO Consulting Senior Scientist, Dr. Brian Tiplady and Bill Byrom from Perceptive Informatics®, the text, “ePRO: Electronic Solutions for Patient Reported Data” can be purchased via invivodata’s on-line ePRO Resource Center.
The groundbreaking textbook reviews the FDA Guidance on PROs in Clinical Research (2009), provides a contemporary view on the use of existing and emerging technology for capturing important PRO data, and answers researchers’ questions around the use of ePRO in clinical drug submissions.
“We are pleased with the comprehensiveness of this text and the response it is already generating from the clinical development community,” said Dr. Tiplady. “By collaborating with some of the leading thought experts in the field - from both industry and the academic world - we have presented clear and precise information on the scientific, technological, and clinical considerations of electronic modalities for patient data collection. We hope that this book will serve as a fundamental reference source for all those interested in ePRO.”
Anyone interested in the text can download a complimentary chapter, “Diary Design Considerations: Interface Issues and Patient Acceptability”, via invivodata’s ePRO Resource Center. There, visitors can purchase the text at a discounted rate and can find a wide variety of current regulatory, scientific, and industry publications and web seminars on PRO- and ePRO-related topics.
“We created the on-line Resource Center to share our knowledge from more than 20 years of designing and implementing innovative systems and processes for capturing valid PRO data,” said Bob Young, Chief Operating Officer at invivodata. “ Dr. Tiplady’s work is a welcome addition to the broad range of tools and topics that researchers can access as they seek practical and current information on PROs and ePRO for their clinical research.”
For additional information on the ePRO textbook and other “industry first” publications by invivodata and PRO Consulting scientists, please visit www.invivodata.com/epro-resources.
About invivodata
invivodata is the only fully-integrated PRO Solutions Organization delivering regulatory-proven strategic consulting and practical ePRO solutions to biopharmaceutical companies who depend upon patient-centered research. From crafting PRO measurement strategy to collecting PRO data electronically, invivodata helps its customers strategically use patient reported data to support labeling claims, enhance market access, 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 solutions have been used in over 300 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 www.invivodata.com.
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 worked on over 150 clinical studies in 50+ indications, has more than 265 years of cumulative experience in psychometrics, PRO study design, and 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 www.patientreported.com
