WCCT’s General Capabilities in Early Phase Clinical Trials

As an early phase CRO specializing in Phase 1 and 2 clinical trials, WCCT Global has a range of capabilities in the pharmaceutical and medical device industries. While we’ve conducted trials across many indications, our primary specialties are in Ophthalmology, Asian Ethnobridging, Vaccines and Viral Challenge, Tobacco and Nicotine, Phase 1 Stable Renal Impairment, and Gastroenterology.

In-patient housing is crucial to our ability to conduct early phase clinical trials, and we currently have housing capabilities for up to 180 volunteers. In addition, our facilities include an accredited safety reference laboratory, a pharmacy with a certified clean room, and dual smoking rooms for nicotine and tobacco trials.

 

Volunteer Recruitment

With our extensive experience we’ve learned to approach volunteer recruitment from all angles to ensure access to a wide range of volunteer types. By fostering physician relationships we’re able to increase exposure to potential volunteers, and we also utilize site marketing, community events and outreach, and recruit through our existing volunteer database. By taking a multifaceted approach, we’re able to customize our recruitment plan based on the specific needs of the Sponsor. This becomes especially important when conducting Ethnobridging trials, which is why we maintain a database of over 55,000 volunteers covering a wide spectrum of ethnicities.  Learn More>

 

Study Design

WCCT has participated in nearly 600 Phase 1 clinical trials, giving us experience with a litany of different study design concepts. Some of the specific study designs and types include: First-in-Human, Single Ascending Dose/Multiple Ascending Dose (SAD/MAD), Pharmacokinetic/Pharmacodynamic, Bioavailability/Bioequivalence, Biosimilars, and more. We’ve implemented a wide range of study types over the past twenty years, and work to ensure that all aspects of each study are tailored to the unique needs of the sponsor.  Learn More>

 

Ophthalmology

Ophthalmology is one of our primary areas of specialty at WCCT, and we’ve conducted successful trials on numerous eye diseases and disorders. Some of these include: Open Angle Glaucoma, Ocular Hypertension, and Dry Eye, among others. We maintain relationships with over 20 ophthalmic research sites nationwide, and have partnerships with over 10 ophthalmologists near our Phase I unit in Southern California to conduct both front- and back-of-eye studies. See the attached video to observe the variety of indications we’ve studied, as well as the design elements we’ve implemented for the specific needs of the sponsor in each specific study.  Learn More> 

 

Ethnobridging

Asian Ethnobridging is another one of our primary areas of expertise at WCCT, specifically Japanese bridging trials. Having conducted over 185 Ethnobridging studies since 2004, WCCT is one of the leaders in promoting global clinical development. To date, WCCT has successfully completed the largest Ethnobridging study ever recorded.

Our volunteer recruitment strategies are integral to our ability to conduct Ethnobridgingstudies, giving us access to a diverse subset of volunteers. Development needs vary, and over time we’ve been able to conduct studies with a wide range of cohort sizes and specific criteria. Learn More>

 

Vaccines and Viral Challenge

Because of our high level of specialization conducting Vaccines and Viral Challenge programs, we’ve been commissioned to work with multiple Sponsors and government agencies to study a wide range of indications, including the widespread seasonal and pandemic influenza. WCCT also owns a strain of the H1N1 virus for use in influenza challenge studies, and has filed an IND for conducting viral studies with the product.

As a highlight of these capabilities, WCCT managed the highest-enrolling Influenza Challenge study ever reported, identifying 180 volunteers with low or undetectable HAI antibodies to H1N1, a subgroup that makes up less than 29% of the population. Throughout the volunteer recruitment process, the team at WCCT conducted nearly 35,000 phone calls to ensure timely recruitment and enrollment for the study.  Learn More>

 

Tobacco and Nicotine

WCCT opened up dual smoking rooms in 2019 to support the clinical data requirements for Pre-Market Tobacco Applications (PMTAs). These capabilities can be applied for Sponsors studying nicotine or tobacco related products, including electronic nicotine delivery systems (ENDS). Engineered for optimal airflow, these state-of-the-art facilities have micro-filtered intake lines to eliminate air contamination and to ensure precision measurements. The dual smoking rooms are fully compliant with all state and local regulations, and give WCCT the ability to utilize our clinical expertise to develop and improve the safety of these products before they enter the marketplace.  Learn More>

 

WCCT is proud to offer wide-ranging programs for early phase clinical trials, all of which can be specialized to meet the specific needs of the client. For more details on these areas of specialization, see the video included in this post.