About PRO Consulting

The scientific consultants of PRO Consulting have over 140 years of cumulative experience capturing and reporting patient reported outcomes data to support more than 270 drug and medical device development programs worldwide. Using this expertise, our scientists can provide input to clinical research teams for making key decisions about how to use patient reported outcomes data (PRO) to support clinical trial objectives.

PRO Consulting has the expertise to:

Assist clinical research teams in choosing the right PRO instrument for clinical trials.
Construct the right sampling strategy for maximizing the sensitivity of the test of a trial’s PRO endpoints.
Build a compelling psychometric dossier behind the PRO measures to the FDA's Study Endpoint and Label Development team to support labeling claims.
Assist sponsors in planning the validation of PRO measures to ensure that they meet the needs of clinical programs and the psychometric validation expectations of the FDA and other regulatory agencies.

What Makes PRO Consulting Different?

Our consultants are “signs and symptoms” experts with unparalleled experience in measuring and collecting PRO efficacy data as primary or secondary endpoints in clinical trials.
Extensive experience with FDA and other regulatory agencies; deep knowledge of latest guidelines and requirements related to PRO data compliance.
Extensive experience and expertise in electronic methods for collecting patient reported outcomes (ePRO).