2010 promises to be the most active year in PRO-related research in a decade
Pittsburgh, PA (Vocus) February 26, 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 opened registration for PROficiency™ 2010 - its 3rd annual educational conference on Patient Reported Outcomes.
Proficiency 2010, the largest conference focused solely on PROs, brings together international professionals involved in the scientific, strategic, operational, and regulatory aspects of PROs in clinical research. The conference agenda features case studies and best practice presentations from international biopharmaceutical researchers on topics related to PRO program and measurement strategy, trial design & execution, and regulatory submissions. Attendees will come away from the conference with more understanding and knowledge to help them:
- Better differentiate their products by incorporating PROs into the early strategy and endpoint planning phases of their research programs.
- Understand and comply with the final FDA guidance on the use of PRO in the development of new medical products.
- Identify, select, and develop PRO instruments that are “fit for purpose” for specific program objectives.
- Seamlessly incorporate ePRO into clinical trial operations to reduce paper, increase efficiencies, and improve the quality of PRO data collected.
"2010 promises to be the most active year in PRO-related research in a decade," said Doug Engfer, invivodata president and CEO. " Given the FDA's Final PRO Guidance and increasing commercial and governmental market pressures, every biopharma researcher must be on top of the best scientific, regulatory, and delivery practices relating to patient-reported data."
The PROficiency conference is the cornerstone of invivodata's continuing educational program that currently has significant focus on the FDA's final PRO Guidance. In addition to attending the conference, biopharma researchers can also participate in invivodata's 2010 Regulatory Web Seminar series:
- Final PRO Guidance: Insight from invivodata (Recording of seminar held Jan. 19, 2010)
- How to Effectively Incorporate PROs into Clinical Trials; March 4, 2010
"Biopharma companies can no longer simply consider using PROs, but must think about how to best measure PROs in their clinical research," said Dr. Jean Paty, Chief Scientist and Regulatory Advisor, PRO Consulting. "PROficiency 2010 and our Web Seminar program will answer researchers' questions about what their organizations must do to conduct compelling PRO research and give them concrete steps to take to successfully define and measure patient reported outcomes."
For additional information and to register for PROficiency 2010 or any of invivodata's Web Seminar programs, visit http://www.invivodata.com.
About invivodata inc.
invivodata combines behavioral science, information technology, and clinical research expertise to capture high quality clinical trial data directly from patients. invivodata’s electronic Patient Reported Outcomes (ePRO) solutions, which are based on over 20 years of research, deliver reliable patient self-reported data by driving patient compliance with the protocol and eliminating recall biases that plague paper-based self-report data. invivodata’s solutions include comprehensive trial-support services that facilitate the collection of ePRO data, web-based access to study data and operational reports that give researchers and sponsors visibility into study progress, and scientific and regulatory consulting on the use of PRO data in a regulated environment. invivodata’s solution has been used in more than 275 clinical programs and is the industry-leading ePRO system in delivering primary efficacy data for FDA 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, Calif., USA. For additional 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 more than 140 years of cumulative experience in psychometrics, PRO study design, migrating and validating electronic solutions to collect PRO data, and has extensive experience working with the FDA and other regulatory bodies. For additional information, visit http://www.patientreported.com