By their name, patient reported outcomes (PROs) require evaluations from the patient’s perspective. As noted in the FDA Guidance*, these evaluations must be made by patients, unfiltered by physicians, family or caregivers.

In order to understand the patient’s perspective you must be able to communicate in simple terms that the patient understands. As a part of Health Outcomes Group’s PROServices™, our trained linguists speak the patient’s local language. They are trained to listen to patients in order to communicate with them in words they normally use. We are experienced in a range of qualitative and quantitative research techniques, including personal interviews, focus groups and a wide range of statistical methods.

—  Translation and linguistic validation
     of PRO instruments

—  Qualitative research
     > personal interviews
     > focus groups

—  Guidance in choice
     of PRO instruments

—  Development of new global
     PRO instruments

—  Evaluation of adequacy
     of study design

—  Statistical plan and analysis
     of PRO data

—  Preparation of dossier
     for regulatory agencies

—  Printing and shipping
     of case report forms