SEPTEMBER 2, 2011 – Pittsburgh, PA – 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 its calendar of complimentary educational programs for those involved in clinical research and its presence at international industry events throughout the remainder of 2011.
invivodata and PRO Consulting will launch its fall educational series on September 8 with a complimentary webinar delivered by Dr. Jean Paty and Celeste Elash of PRO Consulting. The webinar, “PRO Regulatory Update - Migrating Instruments from Paper to Electronic Format” will focus on regulatory recommendations and what needs to be evaluated when migrating a PRO instrument from paper to electronic format. For more information and to register for the webinar, please visit www.invivodata.com.
invivodata’s educational program, PROficiency™ 2011, which provides clinical researchers the latest regulatory, scientific and industry information on PROs in new drug and medical device development, continues throughout September and October with a series of 1-day conferences on the effective use of PRO throughout all stages of clinical research. Occurring throughout the US and Europe, this series gives researchers an opportunity to advance their knowledge on the what, how, and when of successfully incorporating PROs to achieve development objectives and meet regulatory and commercialization expectations. For more information on these regional conferences, visit www.invivodata.com/proficiency-2011-regional-conference-series/.
invivodata and PRO Consulting scientists, product and regulatory experts are also available to meet with clinical researchers at these international industry events, in which they are featured presenters:
- Sep. 11, 2011; Society of Clinical Data Management (SCDM) Annual Meeting; Baltimore, MD.
- invivodata’s Deborah Stapf and Joanne Zuck, M.P.H. Epidemiology, Biometrics and Data Management, Boehringer-Ingelheim Pharmaceuticals, Inc. will present “Preparing for ePRO Regulatory Inspections – Best practices for Smooth and Successful Outcomes.”
- Oct. 10, 2011; Drug Information Association (DIA) Annual Clinical Forum; Basel, Switzerland.
- PRO Consulting’s Dr. Brian Tiplady will present “Web-based ePRO: Validation, equivalence, and data quality.”
- invivodata’s Gretchen Craig will present “ePRO Regulatory Inspections – Best practices for Smooth and Successful Outcomes.”
- Nov. 6, 2011; ISPOR Annual European Congress; Madrid, Spain.
- Dr. Jean Paty will co-facilitate the workshop “Mixing Modes of Patient-Reported Outcomes Data Collection in Clinical Trials: ISPOR PRO Good Research Practice Task Force Report.”
- PRO Consulting’s Dr. Chad Gwaltney will co-facilitate the workshop “Establishing the Content Validity of Patient-Reported Outcome (PRO) Instruments.”
For more information on invivodata’s involvement in these and other industry events, please visit www.invivodata.com/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 350 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
