Our Patient-Reported Outcomes (PRO) Strategy service helps pharmaceutical companies incorporate patient perspectives into clinical development through PRO instruments and endpoints. We select appropriate PRO measures, design endpoint strategies, and support PRO evidence generation. Our approach ensures patient voice is captured in clinical trials and regulatory submissions.
How our patient-reported outcomes (pro) strategy service delivers value to your organization.
Systematic PRO instrument selection based on disease area, concept of interest, and regulatory acceptance.
PRO endpoint strategy aligned with clinical trial objectives and regulatory requirements.
PRO strategy aligned with FDA Patient-Focused Drug Development guidance and EMA requirements.
PRO evidence generation plan including validation studies and qualitative evidence packages.
Comprehensive deliverables that provide actionable intelligence for your team.
A structured methodology that delivers results in four phases.
Identify concepts of interest and patient-important outcomes through literature and patient input.
Evaluate and select PRO instruments based on validity, reliability, and regulatory acceptance.
Design PRO endpoints aligned with clinical trial objectives and regulatory strategy.
Develop PRO evidence generation plan for regulatory submission and label claims.
We work with established PRO instruments including PROMIS, SF-36, EQ-5D, disease-specific measures (EORTC, FACT, HAQ-DI), and can design custom PRO instruments when needed.
Yes, FDA and EMA accept PRO endpoints for label claims when supported by validated instruments, appropriate trial design, and robust evidence packages. We design strategies to support PRO label claims.
We ensure PRO data quality through instrument validation, electronic PRO (ePRO) implementation, data collection protocols, missing data prevention, and statistical analysis plans aligned with ICH E9(R1).
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Learn moreConnect with our team to discuss how our patient-reported outcomes (pro) strategy service can support your goals.
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