We’re pleased to continue adding topics that researchers have expressed interest in, and to share learnings based on our real-world experience with U.S. and international regulators.
Pittsburgh, PA (Vocus) June 4, 2010
invivodata, inc., the industry leader in patient reported outcomes (PRO) solutions and services for global clinical research, today announced two additions to its ongoing, PROficiency™ educational program.
PROficiency is invivodata’s annual complimentary educational initiative, which is designed to help international clinical researchers stay informed on evolving trends and regulations in the use of PRO and ePRO in clinical development. Following the successful completion of its 3rd annual PRO conference, invivodata scientists and regulatory experts are now conducting the following spring programs:
- June 14, 2010: Drug Information Association (DIA) Annual Meeting; Washington, DC. Dr. Jean Paty, invivodata’s senior vice president of scientific, quality, and regulatory affairs, will present, “Electronic Patient-reported Outcomes: Single Versus Multiple Questions Per Screen.” Dr Paty and other scientists from invivodata and its regulatory consulting division, PRO Consulting® will be available in booth #1600 to answer questions pertaining to this and other current published and unpublished ePRO research findings. Please visit invivodata.com for additional information on invivodata’s activities during the DIA Annual Meeting.
- June 24, 2010: Webinar; “ePRO Regulatory Inspection Expectations - Be ready, be agile, be precise!” In this webinar, invivodata’s manager of quality assurance, Gretchen Craig and Sucampo® Pharmaceuticals’ director of international clinical development, Dr. Raymond Panas, will present an ePRO regulatory inspection case study, highlighting inspectors’ key areas of interest, along with recommendations on preparing for and supporting site and system inspections. For more information and to register for this webinar, visit http://www.invivodata.com/eweb/.
“We created the PROficiency initiative in response to increasing adoption of ePRO among clinical trial sponsors and to answer their questions about capturing PRO data in accordance with the FDA Guidance on PROs in Clinical Research,” said Tom Henson, vice president of marketing at invivodata. “We’re pleased to continue adding topics that researchers have expressed interest in, and to share learnings based on our real-world experience with U.S. and international regulators.”
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 nearly 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.
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