Solutions
“The scientific and regulatory experts at PRO Consulting have proved to be a valuable resource, and we look forward to continuing our productive partnership.”
Betsy Williams, Ph.D.
Clinical Science and Strategy Head, Dainippon-Sumitomo Pharma America
Solutions > PRO Consulting
PRO Consulting®
invivodata’s consulting division, PRO Consulting, provides the behavioral science and regulatory expertise that your clinical team needs when making key decisions about how to use PRO data to support clinical trial objectives. Working with trial sponsors, the scientific and regulatory experts of PRO Consulting have supported hundreds of drug and medical device development programs.
With more than 140 years of combined experience capturing and reporting PRO data in a regulatory environment, the scientists of PRO Consulting are the foremost experts in implementing proven methods for collecting patient-reported symptoms data in a regulated environment.
PRO Consulting offers a variety of services to help clinical research teams, including:
- PRO Measurement Strategy & Development Services: helps define and articulate a conceptual framework and endpoint model, establish measurement properties and population-specific relevance, and provide expert guidance and support in regulatory submissions and meetings.
- ePRO Assessment Services: evaluation of migration requirements when moving from paper assessments to an electronic platform, validation of the resulting electronic version of the instrument, and documentation of these efforts to support regulatory submissions.