Strategic Services

Clinical Research: We address the specific challenges of your patient-centered outcome endpoints including study design, endpoint specification, analytical strategy, and alignment with targeted claims. We enable you to fully leverage your data in your regulatory and market access submissions:

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

Regulatory Support: For your regulatory dossiers and meetings, we act as your scriptwriter to develop a compelling account of the evidence you have collected:

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