invivodata and PRO Consulting Scientists to Deliver PRO Gap Analyses and Scientific Presentations at Industry Conferences

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PRO Gap Analysis Identifies Regulatory Risks and Improves PRO Strategies, Tactics

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We were very pleased with the Gap Analysis PRO Consulting conducted with us,” said Ellen Evans, Clinical Team Leader, BTG International. “Their knowledge of FDA’s PRO Guidance was extremely helpful in identifying opportunities to improve our program.

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 a series of upcoming industry conferences in which invivodata and PRO Consulting representatives will be featured presenters.

In addition, invivodata and PRO Consulting scientists are available to meet with clinical researchers at these key conferences to deliver a complimentary PRO Gap Analysis. The 60-minute Gap Analysis is designed to assess PRO instruments from a regulatory standpoint, and to review the reasonable steps researchers can take to reduce risks and ensure the success of their PRO-based clinical development program.

“We were very pleased with the Gap Analysis PRO Consulting conducted with us,” said Ellen Evans, Clinical Team Leader at BTG International. “Their knowledge of the FDA’s PRO Guidance was extremely helpful in identifying opportunities to improve our program and, by working with their scientists, we were able to confidently move forward in accordance with regulations.”

Clinical researchers can visit http://www.patientreported.com/pro-gap-analysis to schedule a Gap Analysis, which can be conducted via teleconference, or in-person at any of the following events which are featuring PRO Consulting scientists and regulatory experts:

  •     American Pain Society (APS) Annual Meeting – May 19-21, 2011; Austin, TX. PRO Consulting Sr. Scientific Consultants Peter Black and Dr. Brian Tiplady will present “Use of Pain Instruments as Endpoints in Regulatory Submissions: Implications of the US FDA’s new PRO Guidance” and “Assessing the Equivalence of Electronic and Paper Data Collection of Brief Pain Inventory (BPI) Data in Rheumatoid Arthritis.”
  •     International Society for Pharmacoeconomics Outcomes Research (ISPOR) Annual Meeting - May 21-24, 2011; Baltimore, MD. Dr. Jean Paty, invivodata Sr. Vice President, Scientific, Quality and Regulatory Affairs and Bob Young, invivodata’s Chief Operating Officer will lead a session on "Implementing ePRO in a Global Clinical Environment". PRO Consulting Sr. Scientist Dr. Chad Gwaltney will present “Patient Symptom Experiences Following a Myocardial Infarction."
  •     CBI’s 8th Annual Patient Reported Outcomes Conference – June 3-5, 2011; Philadelphia, PA. Dr. Brian Tiplady will present “Selecting the Best ePRO Technology for Your Trial.”
  •     Drug Information Association (DIA) Annual Meeting – June 19-22, 2011; Chicago, IL. Dr. Chad Gwaltney will chair the session, "Using Patient-Reported Outcomes to Assess Safety in Comparative Effectiveness Trials: Methodological and Regulatory Issues." Dr. Jean Paty will chair the session, "The Patient Perspective: Start Leveraging this Important Stakeholder to Maximize Commercial Potential." And Dr. Brian Tiplady will chair the session, "ePRO - Which Technologies and Data Management Strategies Provide Maximum Benefit for Your Trial?"

For more information on these and other events featuring invivodata and PRO Consulting scientists, visit http://www.invivodata.com/news-events/events.

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 http://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 http://www.patientreported.com.

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Christine Tobin
invivodata, inc.
412-390-3000 x3502
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