PITTSBURGH, Jan. 12 /PRNewswire/ -- 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(R)( )will conduct a complimentary Web Seminar on the Food and Drug Administration’s (FDA) final Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.
“For those of us who focus on the use of PRO data in clinical research, the publication of this final Guidance is a watershed event that underscores the significant shift we have seen to broader and more effective use of PRO data to support labeling for drug approval and in order to differentiate new products,” said Dr. Jean Paty, invivodata co-founder and vice president of scientific, clinical, and regulatory affairs.
The Web Seminar on the FDA final PRO Guidance is being conducted on Tuesday, January 19th at 11am EST. The discussion will provide analysis and insight into the FDA’s final PRO Guidance to help biopharmaceutical and medical device researchers better understand how to effectively use PRO in their clinical development programs and what they should be doing differently moving forward in light of the guidance.
For additional information on the final PRO Guidance and to register for the complimentary Web Seminar, visit www.invivodata.com/pro.
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 more information please visit http://www.patientreported.com.
CONTACT: Christine Tobin, Corporate Communications Specialist of
invivodata, inc., +1-412-390-3000, ext. 3502, ctobin@invivodata.com
Web site: http://www.invivodata.com/
