With a deep understanding of the regulatory environment and reimbursement issues pertaining to clinical outcome assessments (COAs), we work with you to develop and support optimal measurement strategies for your products in development, including:
- Literature and instrument reviews to guide COA selection and/or to determine that instrument modification or development is needed
- Conceptual model development
- Clinical trial design and consulting to optimize the analysis of COA data, as well as the value of results based on COA endpoints
- Gap analysis of data supporting the use of COAs for your intended purpose
- Collection of qualitative and quantitative data from patients, physicians, and other stakeholders
- Advice on utility assessment strategies to support product value, including the identification of appropriate assessment methods, existing health state utility measures, and PRO instrument mapping algorithms
