Patient-Reported Outcomes

Core Services PRO fact sheet

Development and Support of PRO Measurement Strategies

• Literature and instrument reviews
• Gap analysis
• Clinical trial design
• Utility studies

Instrument Development, Modification, and Adaptation

• Focus groups and in-depth interviews
• Cognitive debriefing
• Item development and modification
• Cross-cultural adaptation

Psychometric Evaluation Psychometrics fact sheet

• Classical methods
• Item response theory (IRT)
• Data collection (independent from clinical trials)

Regulatory Guidance and Support

• Negotiations with FDA and EMA
• PRO Dossiers

Market Research

• Qualitative research
• Surveys
• Sensory panels

Why Choose Our PRO Team?

Strong, multidisciplinary team

• 25 PRO specialists in the US and Europe
• All have advanced academic degrees and significant industry experience
• Collectively conducted thousands of successful PRO projects across therapeutic areas

FDA Experience

• Strong understanding of the FDA's requirements for the support of labeling claims
• Extensive experience with various reviewing divisions and the Study Endpoints and Label Development (SEALD) team

EMA Experience

• Significant experience liaising with the EMA to negotiate the acceptability of PRO endpoints
• Routinely guide industry clients through the EMA's PRO Scientific Advice and Biomarker qualification processes

Related Services
For your projects that may have cross-functional requirements, we also offer the following complementary services:

• Market Access and Outcomes Strategy
• Health Economics
• Health Preference Assessment