PITTSBURGH, PA – January 10, 2011 - PRO Consulting®, the industry leaders in developing strategies and instruments for collecting patient-reported symptoms data in regulated clinical research, today announced that it has expanded its line of Patient Reported Outcomes (PRO) services to support new biopharmaceutical and medical device developers as they implement PROs throughout all stages of their clinical development programs.
While many of the services offered by PRO Consulting are customized to meet individual client needs, developers of biopharmaceutical and medical device products are already benefiting from the expanded portfolio of strategic and tactical services offered by PRO Consulting. Services now being offered include:
- PRO Concept Evaluation & Conceptual Model Development Services
- PRO Instrument Evaluation, Selection, Modification, & Development Services
- PRO Data Management & Statistical Services
- PRO Regulatory Meeting Support Services
- PRO Translation & Linguistic Validation Services
- PRO Scientific Communications Services
- PRO Paper to Electronic Migration Services: Cognitive Interviews and Equivalence Studies
- “We have expanded our services to meet the evolving needs of the biopharmaceutical and medical device industry, and to give them confidence in their PRO data strategies across all stages of their drug development efforts,” said Dr. Jean Paty, PRO Consulting Chief Scientist and Regulatory Advisor. “Given the finalization of the FDA’s Guidance on PROs in Clinical Research, sponsors must be certain that their PRO research strategies and tactics meet regulatory expectations. Our established team of scientific and regulatory experts has the skills and expertise to help sponsors optimize their PRO-based trials and meet regulatory guidelines.”
For additional information on PRO Consulting’s expanded line of PRO services, please visit www.patientreported.com/services.
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 visitwww.patientreported.com
