Clinical Outcome
Assessments Methods

Mixed Methods approach to COA Development

Mixed Methods research is the purposeful collection and analysis of qualitative and quantitative data to explore a research question.

Learn more about Mixed Methods Studies

Exit Interviews

Exit Interviews are in-depth qualitative interviews with individuals, conducted at the end, or soon after the end, of a clinical trial to obtain direct feedbackon their experiences over the course of the clinical trial.

Learn more about Exit Interviews

Prospective, Real-World Study Design and Execution

Before you implement a COA in a pivotal trial, you may want to position COAs in a prospective, real-
world study for the purpose of epidemiological discovery, psychometric evaluation of the COA
measures, or refinement of the target population. At COS, we will design and run observational,
prospective, real-world studies in rare and common conditions to include recruitment and screening of
participants, document development as well as data collection and analysis. We design observational studies to maximize the depth and breadth of insight that will be achieved to allow for clear and transparent decision-making.

Our extensive experience ensures that data are collected and managed using established standard operating procedures. We comply with all relevant legislation and guidance regarding data security, transfer and storage. Our in-house team of COA experts, quantitative scientists, psychometricians and biostatisticians would be happy to talk to you about how we might support your observational study, please contact us.