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Cypress, CA

Phase 1 Clinical Trial Unit

Our largest 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, the Cypress, CA facility is our
primary location for Phase 1 studies. This CPU is dedicated to Phase 1
and can provide housing for long-term, in-house trials, with services for
normal healthy volunteers, ethnobridging, and select patient population
trials.

This 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 it the ability to strategically recruit from a diverse ethnic population of over 15 million.

Many healthy volunteers are also available for recruitment from multiple universities nearby. To ensure the success of your study’s enrollment, the Cypress Phase 1 clinical trial unit’s active outreach team aids community clinical research education and augments our overall patient recruitment efforts.

Other Notable Safety Features

  • 130+ employees trained for Emergency Response situations
  • On-site CLIA-Certified Safety Reference Laboratory capable of conducting hundreds of clinically-significant tests
  • Peripheral Blood Mononuclear Cell (PBMC) processing capabilities
  • USP 797-certified sterile room for parenteral drug preparation
  • 850 ft2 smoking rooms with fully enclosed, isolated air venting systems
Key Features/Capabilities:
Special procedures performed:
  • Pulmonary function testing
  • Bronchoscopy
  • Biopsies
  • Glucose monitoring
  • IV infusion
  • Subcutaneous and intramuscular injections
  • Skin blister
  • X-rays
  • MRIs
  • Vaginal ultrasounds and pap smears
  • Multilingual staff to provide comfortable accommodation and cultural sensitivity for ethnic sensitivity studies
  • Bio fluid collection:
    • Stool
    • Sputum
    • Semen
    • 24-hour urine collection
    • Serial CSF collection and processing
Studies Performed:
  • Ethnobridging/Asian bridging studies
  • DDI, SAD/MAD
  • BA/BE
  • PK
  • FIH
  • Drug delivery (including devices)
  • Food effect
  • Cardiac safety
  • TQT
  • Serial ECGs
  • Telemetry
Equipment/Features:
  • Atomic clocks and watches for time synchronization
  • Six refrigerated centrifuges
  • 12+ ECG machines
  • Three -70º C freezers
  • Multiple -20º C freezers, several 2-8ºC refrigerators
  • Treadmill equipment
  • Slit lamps
  • Goldmann and Perkins applanation tonometers
  • Pupillometers
  • Telemetry and holter-capable
  • Stadiometers, crash carts
  • Nitric oxide machine
  • Platelet aggregometry lab
  • Multiple spirometry units

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, toxicology, drug monitoring, protein analysis, medical conditions, urinalysis, and more.

The laboratory was certified by CLIA to perform testing in early 2017, and is also CAP Accredited.

 

Siemens Advia 1800: Chemistry Testing

 

 

 

 

 

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

Siemens Centaur XP: Special Chemistry and Immunoassay Testing

 

 

 

 

 

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
Sysmex CS-2500: Hemostasis

 

 

 

 

 

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
Clinitek Novus and Auwipro: Urinalysis

 

 

 

 

 

80 tests per hour

Assays:

  • Macroscopic urinalysis
  • Microscopic urinalysis

Siemens Advia 2120

 

 

 

 

 

120 colorimetric samples her hour

Assays:

  • CBC results
  • Differential results
  • Platelet results
  • Reticulocyte results
  • CSF assay results
  • Parameters
  • Morphology results
  • WBC
  • RBC and PLT
Siemens Versacell X3

Fully-automated robotic sample handling system

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