In order to optimize enrollment of early phase clinical trials in patient populations, WCCT has utilized a “Hybrid Model” approach. The major advantages for sponsors are the possibility of greatly accelerated timelines with minimal impact on overall study cost.
This study design capitalizes on the best characteristics of traditional confined clinical and multi-center designs. WCCT enlists the services of local specialists with substantial clinical practices and research experience in a variety of disease states. These established research sites have access to robust patient databases, however, do not have overnight facilities. WCCT partners with these sites to meet our sponsors unique study needs. The research sites identify and screen potential patients at their sites while overnight confinement for dosing, PK and or PD assessments as well as procedure that need to be centralized occurs at WCCT. WCCT has the experienced staff and equipment needed to perform study drug administration and other protocol-related procedures during confinement periods. The WCCT Hybrid Model will enhance recruitment efforts while maximizing data homogeneity and decreasing variability.
WCCT has utilized this model for ophthalmology; asthma and heart failure studies to date, and this model can be applied to a variety of disease states.
In situations where a sponsor has identified robust phase 2/3 investigators in the Los Angeles and Orange County area, WCCT can partner with the sponsor as the supervising CRO and conduct joint feasibility assessments and project manage a multisite phase I program requiring overnight procedures at WCCT overnight facilities.