Clinical Trials
From initial evaluation in humans, through controlled clinical trials, to regulatory approval and
post-marketing surveillance, Westat manages all phases of the clinical development process.
- Westat has conducted several hundred clinical trials, from Phase I initial evaluation through large
multicenter randomized controlled trials to Phase IV post-marketing surveillance. As a
full-service CRO, Westat supports all aspects of clinical product development for government, as well
as pharmaceutical and biotech clients. Westat has conducted clinical trials in pediatric and adult populations in
a wide variety of therapeutic indications, including oncology, infectious diseases, respiratory
diseases, ophthalmology, endocrine disorders, and others. Trials have enrolled from 10 up to 60,000 patients
from as many as 200 sites per trial. Our clinical trial experience includes the following:
- Drug and biologic intervention studies,
- Gene therapies,
- Prophylactic and therapeutic vaccines,
- Pharmacokinetic and pharmacodynamic studies, and
- Trials for evaluation of diagnostic test kits and devices.
- Our data management system is Oracle Clinical, fully compliant with 21 CFR Part 11 and related
FDA/ICH guidances. Adherence to Federal Regulations and Good Clinical Practice is assured by our Regulatory Affairs
Department. General Quality Assurance practices include the following:
- Adherence to standard operating procedures,
- Protocol-specific staff training,
- Site monitoring,
- Forms design practices,
- Database design practices, and
- Systems security.
Visit Westat's International Health Research page to learn more about our global clinical trials experience.
Click here for more about Clinical Trials at Westat.
