Early Clinical Development (Phase 1 Clinical Trials)
WCCT Global offers an adaptive approach for better quality decisions with reduced risk through extensive Risk Mitigation and Contingency Planning.
Since 1998, WCCT Global has conducted over 500 Phase 1 clinical trials for the research and development of specialized medicines and therapies. WCCT is an industry expert in managing and conducting early phase research at its clinical Phase 1 unit in Cypress, CA, and nationwide.
WCCT Global’s corporate owned and operated Phase 1 clinical trial unit is strategically situated within a large metropolitan area to recruit from a diverse ethnic population of over 15 million. This 75,000-square-foot facility is capable of housing up to 180 subjects at a time for overnight stays and outpatient visits. Read more about our Phase 1 unit in Cypress, CA.
Our Adaptive Approach to Phase 1 Clinical Trials
WCCT Global provides an adaptive approach to designing Phase 1 clinical trials that makes use of data not currently available at study start-up as a basis for modifications to the trial design. This process, combined with our risk mitigation strategy, offers the opportunity for better quality decisions, reduce untoward early clinical development events, fewer patients required for development and reduced cost.
As both a Phase 1 CRO and owner of a clinical Phase 1 unit, WCCT Global promises an adaptive, flexible Phase I clinical trial design that is individually tailored to the efficient, economic and expedited development of your compound into commercial reality.
Phase 1 CRO Selection
When selecting a Phase 1 CRO to oversee your Phase 1 clinical trials, sponsors should ensure that they are incorporating these key adaptive modifications into their trial design:
- Sample size adjustment
- Changing randomization fraction:
- to favor certain treatments
- to avoid unfavorable treatments
- Addition of special patient populations
- Addition of specific ethnic populations
- Addition of new treatment arms
- elimination of other treatment arms
It is through this approach, as a Phase 1 CRO, that WCCT Global has made great strides in the early clinical development of many specialized therapies, medicines and drug delivery devices. WCCT offers its sponsors a reliable, flexible and collaborative drug development partner to start their compound on the path to market approval success. We do this by combining use of our phase one units, clinical research sites, and strategically-implemented CRO services.
Back-End Services for Phase 1 Clinical Studies
WCCT has extensive capabilities in providing back-end services to support the development, planning, management, and operations of Phase 1 programs. These services are offered as a standalone items or as a full suite in-house at our Phase 1 facility:
- Protocol Development
- Medical Writing
- Regulatory Support
- Project Management
- Data Management
- Clinical Monitoring
- Medical Monitoring & Safety
Therapeutic Expertise for Phase 1 Trials
As a Phase 1 Unit, WCCT has conducted clinical studies toward the development of treatments in a variety of therapeutic areas, including:
- Infectious Disease/Vaccines
Additionally, WCCT is an industry leader in conducting Asian Bridging/Ethnobridging programs, specifically in first-generation Japanese populations.
Phase 1 Resources
10 Questions to Ask Clinical Phase 1 Units
It’s not unusual for Sponsors to establish shortlists of clinical Phase 1 units. What questions should they be asking to ensure the best overall study?
Reduce the Cost of Phase 1 Clinical Trials
How can Sponsors reduce the cost of Phase 1 clinical trials? A deep analysis of a Phase 1 site’s operations and staffing procedures is the answer.
Webinar: Phase 1 Patient Study Recruitment
WCCT hosted a webinar discussing strategies for the successful alignment of late-stage investigators and sites into the Phase 1 model.
Webinar: Proper Selection of Phase 1 Units
WCCT Global hosted a webinar discussing items to consider when selecting or reviewing clinical Phase 1 units. View the live recording.
Early Clinical Development
The blog delivers industry-related developments and announcements regarding expanded clinical services.