In accordance with regulatory guidelines and expectations in the US and Europe, we can help you develop new COAs and modify existing measures to support your product approval and labeling claims. We also identify and develop COAs to support reimbursement decisions and publication strategies.
We have developed and evaluated the psychometric properties of hundreds of PRO instruments and other types of COAs to assess health outcomes, such as symptom severity, health-related quality of life, functional status, and patient satisfaction for use in clinical trials involving both pediatric and adult patients across a wide range of conditions. In addition, we have experience developing COAs for use in routine clinical care, such as patient screeners and disease management tools.
Our instrument-development services apply to all modes of administration (e.g., paper, eCOA, web-based) and include:
- Reviews of the literature and existing instruments to inform the conceptual basis for new COAs
- Integration of experts to ensure clinical relevance
- Focus groups and in-depth interviews with targeted populations to elicit concepts of importance
- Application of standard methodological principles to develop initial item pools
- Cognitive debriefing interviews to test and refine COA instructions, questions, and response scales
- Translatability assessment and cross-cultural adaptation
- Migration to alternative modes of administration
- Qualitative and quantitative analysis
- Development of documentation, including regulatory submissions, reports, and publications
- Support to secure regulatory acceptability of COAs
- Evaluation of feasibility and acceptance for routine clinical care applications