Support for Late-Phase Studies

Support for Late-Phase Studies

ClinArt’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:

ClinArt 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. The other support services are:

  • 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
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