End-to-End Patient-Centered Outcomes Research From Concept to Claim
A Concept-Driven Approach for Measurable Impact
Patient-centered outcome strategy
Strategic guidance to help sponsors navigate the complex landscape of endpoint selection and development, aligning with regulatory expectations and the patient experience.
Learn moreInstrument development expertise
Our instrument development capabilities span the full lifecycle from conceptual framework through psychometric validation, meeting the highest standards of measurement science.
Learn moreLet our team help you navigate the path from concept to claim
Advancing Patient-Centered Outcomes
Outcome Strategy
Strategic guidance on patient-centered outcome selection and endpoint development for regulatory submissions.
Instrument Development
Development and validation of patient-reported outcome measures tailored to your therapeutic area.
Implementation & Use
End-to-end support for implementing outcome measures in clinical research settings.
Training
Comprehensive training programs for study teams on patient-centered outcome assessment best practices.
Mixed Methods Expertise
Combining qualitative and quantitative research methods to develop robust, patient-centered endpoints.
Digital Health Technologies
Leveraging digital tools and technologies to capture and analyze patient-centered outcomes data.
Have Questions?
Here are a few answers about patient-centered outcomes, measurement strategies, and our approach to clinical research support.
What defines a patient-centered outcome?
A patient-centered outcome is a health outcome that is meaningful to patients, reflecting their experiences, functioning, and quality of life. These outcomes are developed with direct patient input to ensure they capture what matters most.
How are outcome measures developed?
Our concept-driven approach begins with understanding the patient experience through qualitative research, then develops and validates instruments using rigorous psychometric methods aligned with FDA and EMA guidance.
Why use mixed methods research?
Mixed methods combine the depth of qualitative research with the rigor of quantitative analysis, providing a comprehensive understanding of patient experiences that strengthens endpoint strategies and regulatory submissions.
How are solutions customized?
We leverage digital health technologies and electronic clinical outcome assessment (eCOA) platforms to automate data collection, scoring, and analysis of patient-centered endpoints in real time.
What implementation support is available?
Our team provides full implementation support including site training, translation and linguistic validation, regulatory advisory services, and ongoing technical assistance throughout your study.
Is team training offered?
Yes, we offer customized training sessions for study teams covering patient-centered outcome assessment, instrument administration, data collection best practices, and regulatory considerations.
Proven Expertise
Our experience in patient-centered outcomes research
PCOR Experience (yrs)
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Therapeutic Areas
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COA Instruments
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Scientific Publications
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