Strategic Services

Clinical Research

We help our clients identify and address specific challenges related to patient-centered outcome endpoints, including study design, endpoint specification, analytical strategy, and alignment with targeted claims. Our expertise enables our clients to fully leverage their data in regulatory and market access submissions:

• Design, analysis, and interpretation of clinical outcome assessment endpoints
• Study design and protocol development
• Development of pre-specified or post-hoc statistical analysis plans
• Analysis and interpretation of COA endpoints
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Regulatory Support

Our dedicated researchers provide tailored consulting services to support regulatory dossiers and meetings. We collaborate with clients to develop a compelling narrative to help translate evidentiary findings for regulatory consideration:

• Context of use (condition description, study population, targeted claim)
• Concept of interest
• Content validity
• Measurement properties
• Administration and scoring manuals
• Interpretation