PRO-Measurement

ePRO Services

PRO Measurement Strategy & Development Services

Ensuring that your patient reported outcomes (PRO) data meets the scientific and regulatory rigor expected by FDA and other regulatory agencies requires expertise that may not be available within your organization. Selecting, developing or modifying, testing, validating, and documenting PRO measures and approaches for efficacy endpoints in your clinical trial programs can be challenging. PRO Consulting provides the focused expertise needed to properly design and develop your PRO research studies including choosing between electronic patient reported outcomes technology or traditional paper-based methods.


PRO Consulting offers an array of services to help you 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. PRO Consulting services will provide you with the confidence that your PRO measures will best support your labeling claims. PRO Measurement Strategy & Development Services include: