Patient-reported outcomes and clinical outcome assessment strategy
Supporting selection, validation, translation, ePRO migration, and custom questionnaire development to capture meaningful patient insights
Our expertise
At Vitaccess, we develop patient-reported outcome (PRO) and clinical outcome assessment (COA) strategies that deliver meaningful, actionable insights.
Tailoring PRO / COA strategies to your needs, whether that involves a robust, multi-method plan with stakeholder engagement or a pragmatic desk review, ensuring that patient insights are meaningful, credible, and ready to inform action.
Capturing what matters most to patients and caregivers
Instrument selection and licensing
Linguistic validation and translation
Our experts ensure instruments are accurately translated and culturally adapted for each target population. Following FDA, EMA and ISPOR best practices, we perform linguistic validation to maintain conceptual equivalence, enabling the capture of meaningful and reliable patient-reported data across multiple languages and regions.
Electronic migration (ePRO)
We support the migration of paper-based or legacy PRO/COA instruments to electronic platforms, ensuring regulatory compliance, usability, and data integrity. Our team validates the digital version to provide a seamless, patient-friendly experience while maintaining scientific rigor.
Custom questionnaire development and validation
When no suitable instrument exists, we design and validate bespoke PRO or COA questionnaires tailored to your study objectives. Our approach can combine qualitative research, psychometric validation, and regulatory guidance to generate robust, meaningful patient insights for trials or real-world studies.
