Clinical Outcomes Assessment Development

Designing and validating your patient-reported outcomes (PRO)

Oracle Life Sciences can design and validate your patient-reported outcomes (PRO) and observer-reported outcomes (ObsRO) instruments to precisely measure health outcomes or aspects of quality of life from patients’ and caregivers’ perspectives. In our development phase, we can craft the instrument to accurately capture patient experiences and symptoms using concept elicitation and item generation. Our scale validation, which includes cognitive debriefing interviews and psychometric validation, then verifies the instrument’s relevance, reliability, and accuracy. Harness the resulting PRO instruments in your clinical trial planning, drug design, regulatory decisions, and real-world evidence generation.

Insight across diverse cultures and borders

If your PRO/ObsRO tool will be used internationally or among different cultural groups, any translations must maintain the instrument's original meaning and intent. We provide rigorous linguistic and cultural adaptation support to meet this need.

An experienced team with a proven track record

The Oracle Life Sciences team is composed of outcomes researchers, methodologists, and statisticians who bring extensive experience in new measure development and measure utilization across numerous therapeutic areas. The team’s market- and disease-specific expertise can be observed in more than 2,000 scientific publications, including articles, posters and abstracts.

The depth of Oracle expertise in patient-reported outcomes is also reflected in the Oracle Life Sciences National Health and Wellness Survey (NHWS), the largest database of projectable, self-reported patient outcomes and health information. The NHWS includes 35 validated scales and disease-specific assessment measures, providing rigorous patient-reported data on outcomes, attitudes, behaviors, characteristics, and demographics, with national projections on more than 200 conditions in 12 countries.