Support for Late-Phase 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. This experience is extremely important because of the Food and Drug Administration (FDA) Amendments Act of 2007. This legislation may require pharmaceutical and biotechnology companies to adjust their strategies for conducting post-approval studies.

Comprehensive Study Phase Support

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 design, implement, and manage late-phase studies from inception to successful completion.

Services

Phase 3b
Phase 4
Drug/disease registries
Patient-reported outcomes (PROs)
Outcomes research
Patient satisfaction
Safety surveillance
Drug effectiveness
Quality of life issues
Cost-effectiveness
Pharmacoepidemiology