COA Development & Validation

Comprehensive insight into every COA tool

Our dedicated team of experts supports all phases of clinical outcome assessment (COA) development – from the earliest stages of planning to testing and validation. We help you design COA tools and protocols for use in clinical trials and other applied healthcare settings around the globe. Know immediately whether you’re asking the right questions and building the right context for making the most accurate assumptions.


Our services put you in an optimal position for extracting comprehensive, scientifically valid evidence under the critical lens of your therapeutic area.

Qualitative Methods

To ensure your COA tools are relevant, comprehensive, and understandable, our in-house qualitative research teams conduct concept elicitation and cognitive debriefing interviews with patients, caregivers, clinicians and key opinion leaders.

Quantitative Methods

Our quantitative researchers and analysts are trained in both classical test theory and modern psychometric methods (Rasch and Item Response Theory). They work alongside your teams to generate the psychometric evidence needed to support the use of your COAs in treatment trials and other clinical applications according to FDA guidelines.

A fit-for-purpose approach

We utilize both qualitative and quantitative approaches to ensure that your COA strategy is aligned with regulatory requirements, including the development of COA dossiers and regulatory briefing packages, and Type B/C meeting preparation and participation.