NOVEMBER 16, 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 opened registration for PROficiency™ 2012: PROs and Beyond, its 5th annual conference on the collection of patient perspective in clinical research.
This premiere conference will address the many questions clinical researchers have about recent regulatory changes pertaining to selecting, evaluating, and providing evidence to support endpoints for their clinical development programs. In October 2011, the Food and Drug Administration (FDA) conducted a public workshop to discuss measurement principles for outcome assessments (OAs) used in clinical trials for new drugs, including PRO measures, clinician reported outcome (ClinRO) measures, and observer reported outcome (ObsRO) measures. By attending PROficiency 2012, new product developers will have access to current, critical information on the regulations and practical considerations of selecting, implementing, and defending OAs throughout all stages of clinical development to ensure they are fit for purpose and appropriate for their context of use.
An esteemed faculty of international researchers and regulatory experts from the biopharma industry will deliver current, practical information and case studies of their clinical experience at PROficiency 2012. A sampling of confirmed speakers includes:
- Tom Hare, Vice President of Drug Development Operations at Incyte® Corporation, where he oversees the conduct of Phase I through Phase III investigational drug clinical trials
- John H. Powers III, MD FACP FIDSA, Physician/Investigator on faculty as the Associate Clinical Professor of Medicine at the George Washington University School of Medicine and former Lead Medical Officer for Antimicrobial Drug Development and Resistance Initiatives in the Office of Antimicrobial Products, Center for Drug Evaluation and Research, at the US Food and Drug Administration where he was responsible for issues related to clinical trials and policy in antimicrobial research
- Eric Gemmen, Senior Director of Epidemiology & Outcomes Research, Late Phase Division at Quintiles®, where he writes protocols and directs statistical data analysis for Phase IV and observational studies, and designs and implements prospective health outcomes studies
“We are very excited for next year’s conference,” said Dr. Jean Paty, invivodata’s Co-Founder and Chief Regulatory and Scientific Advisor and Chief Scientist and Regulatory Advisor for PRO Consulting. “Attendees will have access to international experts who can address their questions related to the effective use of OAs in clinical development. It is our goal to ensure that attendees come away from the conference with knowledge of the scientific and regulatory considerations of capturing patient perspective in clinical development – practical input that can be used day-to-day in their clinical research.”
invivodata is offering 30% off of conference fees for attendees who register before Feb. 1, 2012. For more information and to register, visit www.invivodata.com/PROficiency2012.
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
