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Patient-Reported Outcomes

Making sure the voice of the patient is heard

Our multidisciplinary PRO team can help you assess the impact of diseases on patients and demonstrate the drug benefits most important to them.

We work collaboratively with our clients to provide payers, providers, and regulators with a better understanding of the patient experience.

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:


 
CONTACT US

 
Carla DeMuro, MS
Head, Patient-Reported Outcomes
Dana B DiBenedetti, PhD
Head, Patient-Reported Outcomes
Lynda Caroline Doward, MRes
European Head, Patient- Reported Outcomes
Sheri E Fehnel, PhD
Vice President, Patient-Reported Outcomes
Susan Anne Martin, MSPH
Senior Director, Patient-Reported Outcomes
Lori D McLeod, PhD
Head, Psychometrics
Diane Whalley, PhD
Senior Director, Patient-Reported Outcomes

US: +1.800.262.3011
Spain: +34.93.241.7766
UK: +44(0)161.232.3400
For a full list of scientific staff bios, click here.

 

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