From initial evaluation in humans, through controlled clinical trials to regulatory approval and post-marketing surveillance, our team manages all phases of the clinical development process. Westat regulatory affairs experts have extensive FDA experience to manage INDs and other submissions through the regulatory process. Experienced clinical project managers, systems analysts, data quality managers, and biostatistical and analytic staff comprise the team to implement the Phase I-IV clinical development program.

Westat’s extensive experience in epidemiology, health economics, and health survey research provides evidence of our capabilities for collecting data from medical providers, patients, and public databases. This experience allows Westat to define appropriate patient populations for drug development and integrate disease etiology, outcomes, economic factors, and quality-of-life considerations into the clinical development process.