Services

Endpoint Model Development

PRO Consulting scientists apply their pharmaceutical and measurement expertise to work collaboratively with you in identifying the conceptual link between the disease state, your drug compound, biologic or device and its effects on key patient signs and symptoms, and finally the impact on the patient’s quality of life.

The endpoint model will:

identify the relevant PRO and other endpoints associated with a specified drug and/or clinical program,
inform the appropriate measurement strategies necessary to accurately evaluate those endpoints, and
provide instrument selection documentation that is consistent with recommendations by regulatory authorities.

We will perform a thorough literature review and meet with your experts and key opinion leaders (as necessary) around the disease state or treatment of interest to collaboratively build the endpoint model.

The final endpoint model report includes:

Graphical representation of the model
Table of endpoints
Series of abridged recommendations for endpoint measurement
Text and references in support of our findings and recommendations