Conceptual Model Development
Can you defend to regulatory bodies how your targeted concepts (i.e., subjects’ “pain points”) are linked to your desired label claims?
Our Conceptual Model Development Services enable sponsors to characterize and explain the relationship(s) between the concepts and the targeted endpoints.
| Service | Description |
| Concept Model Development | We will develop a model that links the patient population, product’s mechanism of action, and the resulting effects on signs, symptoms, and the impact of these on the patient (e.g., health related quality of life) |
| Concept Justification | We will document the information that supports key concepts (signs, symptoms, and impacts) that are identified in the conceptual model |
