Phase 1 Unit
Phase 1 Clinical Trial Unit
Our clinical pharmacology unit is designed specifically for Phase 1 clinical trials and is uniquely positioned to meet your high-volume enrollment needs.
Cypress, CA
With 75,000 sq. ft. and 180 beds, this CPU is dedicated to early phase trials
and can provide housing for long-term, in-house trials, with services for
normal healthy volunteers, ethnobridging, and select patient population
trials.
The Phase 1 unit is uniquely positioned between the Orange County and Los Angeles areas (Los Angeles County – 9.3 MM, Orange County – 2.7 MM, Riverside/San Bernardino Counties – 3.1 MM), giving us the ability to strategically recruit from a diverse ethnic population of over 15 million people.
Many healthy volunteers are also available for recruitment from multiple universities nearby. To ensure the success of your study’s enrollment, the Phase 1 clinical trial unit’s active outreach team aids community clinical research education and augments our overall patient recruitment efforts.
Other Notable Features
- 130+ employees trained for Emergency Response situations
- On-site CAP and CLIA-accredited Safety Reference Laboratory capable of conducting hundreds of clinically-significant tests
- Peripheral Blood Mononuclear Cell (PBMC) processing capabilities
- USP 797-compliant sterile room for parenteral drug preparation
- 850 sq. ft. smoking rooms with fully enclosed, isolated air venting systems
Special procedures performed:
- Bronchoscopy
- Bio-fluid collection: stool, sputum, semen, emesis, urine, CSF
- Biopsies
- Cystoscopy
- Glucose monitoring
- Holter Monitoring & Telemetry
- Skin testing
- Peripheral Blood Mononuclear Cell (PBMC) processing
- Pulmonary function testing including Bronchial Challenge Testing
- Vaginal ultrasounds and pap smears
- Various ophthalmic tests
- X-rays & MRIs
- FIH
- SAD/MAD
- PK/PD
- BA/BE
- Biosimilar
- DDI
- Drug delivery
- Device
- Food Effect
- Cardiac safety
- TQT
Early Clinical Development
Safety Reference Laboratory
WCCT’s fully-automated safety reference laboratory is housed within our Phase I clinical trial unit. This lab is capable of conducting hundreds of clinically-significant tests for chemistry, hematology, toxicology, drug monitoring, protein analysis, medical conditions, urinalysis, and more.
The laboratory is CAP and CLIA accredited since 2017.
1200 Colorimetric tests and 600 ISE test per hour
Assays:
- Drug Abuse and Toxicology:
- Specific Proteins
- Therapeutic Drug Monitoring
- General Chemistry
- Validity Testing
- Creatinine
- Nitrite
- Oxidant
- pH
- Specific Gravity
240 Direct Chemiluminescence test per hour
Assays:
- Allergy
- Anemia
- Autoimmune
- Bone Metabolism
- Cardiac
- Diabetes
- Hepatitis
- HIV
- Immuno-suppresant Drugs
- Inflammation
- Liver Fibrosis
- Metabolic
- Oncology
- Sepsis
- Special ID
- Reproductive Endocrinology
- Therapeutic Drug Monitoring
- ToRCH
- Thyroid
180 tests per hour of chromogenic immunoassay, and aggregation assays
Assays:
- PT
- aPTT
- Fibrogen
- Thrombin Time
- Batroxobin Time
- Factor Deficiency
- Lupus anticoagulant
- Protein C pathway
- Heparin
- D-DImer
- Von Willebrand Factor
- Chromogenic
80 tests per hour
Assays:
- Macroscopic urinalysis
- Microscopic urinalysis
120 colorimetric samples her hour
Assays:
- CBC results
- Differential results
- Platelet results
- Reticulocyte results
- CSF assay results
- Parameters
- Morphology results
- WBC
- RBC and PLT
Fully-automated robotic sample handling system
Early Clinical Development Expertise
With over 500 Phase 1 clinical trials completed for the development of specialized therapies and medicines, WCCT has developed a comprehensive portfolio of expertise in early clinical development
Volunteer Recruitment
Volunteer recruitment is one of the leading causes of missed deadlines and failed studies. Avoid these fallbacks with a trusted team of experts utilizing data-driven solutions to meet your study enrollment goals.
Ethnobridging Studies
Gain access to one of the highest immigrant Asian-American populations in the U.S. through WCCT’s owned-and-operated Phase 1 clinical trial unit. We have managed the successful completion of multiple ethnobridging studies on time and within, or even before, the original timeline set by the sponsor.
Ophthalmology Studies
WCCT Global offers an end-to-end solution for conducting Phase I-II ophthalmic clinical trials. We combine site ownership with a network of ophthalmology research centers, investigators, and KOLs to provide its partners the services necessary to accelerate the development of new treatments.
Viral Challenge and Vaccine
WCCT is the first commercially-approved U.S. site that can drive and accelerate influenza clinical trials through strategic identification of seronegative volunteers and optimal timing of enrollment. We offer sponsors the freedom to conduct vaccine research in a secure environment.
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