PCOR Services
What we do
Patient-centered Outcomes
VPG Health’s PCOR division brings the voice of the patient into the development and evaluation of clinical outcome assessments (COAs). We employ FDA’s Patient-Focused Drug Development guidance documents, core theories that underlie qualitative research, such as phenomenology and semantics, and gold-standard psychometric methods to gather and analyze comprehensive data about people’s experiences with health and disease. This cohesive approach allows us to ensure the patients’ perspectives on outcomes that are important to them are captured and appropriately interpreted through COAs.
Qualitative Research
• Landscape Analysis
• Protocol Development & Implementation:
· Interviews
· Focus Groups
· Literature/Landscape Reviews
• Conceptual Model Development
• COA Stakeholder Engagement
• Meaningful change
Statistical/Psychometric
Analysis Plan Development
• Study design and endpoint refinement
• Statistical analysis plan development
• Continuous and discrete endpoint analyses
• Planning and execution of post-hoc analyses
• Simulation studies
• Power Analysis
Psychometric Analyses
• Measurement/Scoring Model Support
• Reliability Estimation
• Validity Evidence for:
· Convergent/Discriminant Relationships
· Known Groups Differences/Change
· Sensitivity to Change
• Meaningful Score Differences/Regions
• Simulation Studies
COA-focused Regulatory
Support
• Endpoint strategy
• Evidence-based rationales
• COA evidence packages
• Submission/meeting packages
• Regulatory comments/responses
• Scientific Communications
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