ePRO: Focus on Site-Based Assessments
Pittsburgh, PA (Vocus) September 22, 2010
PRO Consulting®, the industry leaders in implementing methods for collecting patient-reported symptoms data in regulated clinical research, today announced it will host a series of webinars on current trends in the capture of Patient Reported Outcomes (PRO) data. The series is a component of PROficiency™, an ongoing educational initiative which PRO Consulting provides to clinical researchers in conjunction with its parent organization, invivodata®, inc.
PRO Consulting’s team of 15 scientists is at the forefront of PRO research, drawing from its experience in over 50 indications to provide input to clinical research teams making key decisions about PROs in support of clinical trial objectives. The webinar series will feature veteran scientists and regulatory experts presenting current topics related to the measurement and collection of PRO efficacy data in international clinical development, highlighting
- “How Do You Know Your Drug Works?” Featuring Dr. Jean Paty; Sept. 30, 2010
- “ePRO: Focus on Site-Based Assessments,” Featuring Dr. Brian Tiplady; Oct. 26, 2010
- “ePRO Regulatory Environment in Europe,” Featuring Katarina Halling; Nov. 11 & 16, 2010
Now in its third consecutive year, the PROficiency educational initiative is designed to answer researchers' questions about the successful use of PROs in clinical research. The initiative includes a variety of complimentary programs geared toward researchers in all stages of clinical development, regardless of their knowledge or experience with Patient Reported Outcomes.
“The work we have done with over 45 biopharmaceutical companies to date continues to expand our knowledge of what, why, when, and how to conduct compelling PRO research”, said Dr. Jean Paty, PRO Consulting Chief Scientist and Regulatory Advisor. "We are committed to sharing that knowledge with developers of biopharmaceuticals and medical devices who are looking for direction on successfully defining and measuring patient reported outcomes in a regulatory environment.”
For more information on PROficiency and to register for any of the webinars, visit http://www.invivodata.com/eweb/.
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 and 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.
invivodata is the only fully-integrated PRO Solutions Organization (PSO) delivering regulatory-proven strategic consulting and practical ePRO solutions to biopharmaceutical companies where patient-centered research is a priority. From consulting on scale selection and study design to direct data collection from patients using invivodata’s ePRO solutions, and then assisting in regulatory filings and meetings, invivodata helps its customers strategically use patient reported data to support labeling claims and other clinical program objectives. And through partnerships with leading CROs and eClinical technology providers, invivodata seamlessly integrates into the clinical trial ecosystem, effectively contributing to the harmonization of each function to minimize scientific and clinical risk while maximizing efficiencies. invivodata’s solutions have been used in over 300 clinical programs and is 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, Calif., USA. For more information, visit http://www.invivodata.com.