Refining Patient Reported Outcomes
PRO Consulting Services
PRO Consulting provides the expertise that your clinical research team needs when making key decisions about the PRO strategy and instruments for clinical programs and individual trials. Our scientific consultants have over 140 years of cumulative experience in psychometrics, PRO study design, and implementing electronic solutions to collect PRO data of the highest integrity. We have guided the capture and reporting of PRO data in over 300 drug and medical device development programs worldwide.
PRO Consulting is unique in that our expertise lies in collecting efficacy data in clinical trials. We know how to optimally select PRO measures to assess your treatment effect, and support your decisions with regulatory bodies. Our expertise is in the area of measuring signs and symptoms that are the basis of the primary endpoints in clinical programs and trials. No one knows more about collecting definitive patient reported “efficacy” outcomes data than our group of experts.
Our consultants have extensive experience with the FDA and other regulatory bodies. We routinely support clients in preparing for FDA meetings, and attend these same meetings as appropriate.
What Can PRO Consulting do for You?