PRO instrument development
Oxford Outcomes has well-established expertise in all stages of the PRO instrument development process and have developed a broad range of instruments designed to capture PROs in clinical trials, observational and clinical settings. Our instruments include measures of; symptoms, health related quality of life, treatment satisfaction, patient preference, functional status and utilities as well as symptom diaries and patient screening and diagnosis.
Our team brings together opinion-leading scientific expertise, knowledge of marketplace and regulatory landscapes, together with consultancy skills and deep understanding of client needs. The team also contributes to the scientific advancement of PRO instrument development and debate on several fronts including FDA policy development, ISPOR, DIA SIACs and the EuroQol Group. For more about the team and their recent publications click here.
We develop PRO instruments which will deliver results to support FDA or EMA labeling claims, we ensure that robust methodology and validated measurement properties are supported by full documentation. Investigators in most major markets, who assist by providing country and culture-specific guidance, as well as in-country data collection, facilitate our PRO team. Utilizing the knowledge and skills of the entire Oxford Outcomes team we offer a complete instrument development service encompassing both the scientific and commercial aspects of our clients needs.