Support for Late-Phase and Post-Marketing Studies

Westat’s experienced clinical trials staff have helped clients design and conduct a full range of phase 4 and other late-phase or post-approval studies. These types of studies are increasingly relevant following the passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA). This legislation may require pharmaceutical and biotechnology companies to adjust and enhance their activities for conducting post-approval studies.

Westat has epidemiologists, biostatisticians, survey statisticians, economists, market researchers, and field staff who provide expertise required to support late-phase studies.

From short-term patient satisfaction surveys, to monitoring and evaluating safety and outcomes, our professional staff can effectively design, implement, and manage late-phase studies from inception to completion.

Services

Phase 3b
Phase 4
Registries (drug, disease)
Patient-reported outcomes (PROs)
Outcomes research
Patient satisfaction
Safety surveillance
Comparative effectiveness research (patient-centered outcomes research)
Quality of life issues
Cost-effectiveness
Pharmacoepidemiology