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 statistical analysis

There are a number of important reasons for having PRO data analyses undertaken by experts with deep understanding of PROs and psychometrics. Statistical analysis of PRO data is increasingly regulated by agencies including the FDA and EMA. This is partly because PRO data raises a number of specific statistical issues including: multiplicity, missing data, and interpretation. For this reason analysis, interpretation and reporting of PRO data benefits from involvement of specialists with knowledge of PROs and the current regulatory environment.

 

We provide our clients with a range of PRO statistical services including:

• Development of PRO statistical analysis plans.
• Analysis of trial data for regulatory approval.
• Psychometric testing and assessment of PRO and ePRO measures using factor analysis, Item Response Theory, Rasch analysis, and structural equation modeling techniques.
• Crosswalks and mapping studies.
• Preference weighting.
• Modeling of conjoint analysis data.

Our team includes staff with combined PRO and statistical expertise. They are able to conduct data analysis in SAS, STATA, or SPSS according to client needs. For more information about our team please click here.