Patient Reported Outcomes

• Conceptual and endpoint models
• Discrete choice experiments
• ePRO SERVICES
• Market Research
• PRO evidence dossiers
• PRO instrument development
• PRO Statistical Analysis
• Strategic PRO advice
• Systematic and focussed literature reviews
• Training
• Translation and Linguistic Validation of PRO measures
• Utility and Patient preference studies

PRO evidence dossiers

PRO evidence dossiers provide regulators with the documentary evidence to support the use of PRO measures. They typically cover: complimentary research, PRO development methods, reliability, validity, and applicability of the instrument within a specific therapeutic area. The PRO dossier is typically presented in a standard format, and communicates measurement plans in support of regulatory submissions to the FDA or EMA.

 

Oxford Outcomes is a well-established market leader in developing PRO evidence dossiers. Our team of PRO researchers brings together writing and communication skills, with knowledge of marketplace and regulatory landscapes. We have a track record of assisting our clients in their exchanges with regulatory agencies such as the FDA's SEALD committee. For more about the team and their recent publications click here.