Early Phase Research

early phase research

Early Phase Research clinical studies are an integral part of the research process with the need for the highest standards in facilities, patient safety, and technology.

We pride ourselves in offering unmatched service during every aspect of an early phase research clinical trial, from developing the methods in perfecting proof of concept to the last patient enrolled. With thousands of patients enrolled and years of experience, you can rest assured that during every step of our Phase I process, our mission is to achieve the success of your trial. We focus on simplifying the most complex of trials and providing a service that is unparalleled by others in the industry.

More Information:

WCCT Global owns and operates two large clinical pharmacology units with a combined 210-bed capacity. We are known to be the premier site for First-In-Human (FIH), complex early phase research trials (such as CSF sampling, TQT and other cardiac safety trials, flu challenge), and ethnic sensitivity trials, in addition to traditional Phase I-IV and BE/BA studies including patient and special population trials. Both units are located within two large metropolitan areas, strategically situated to recruit from a very ethnically diverse population of over 13 million people (Los Angeles County – 9.3MM, Orange County – 2.7MM, and Riverside/San Bernardino Counties – 3.1MM). There are also several major universities and community colleges nearby for recruitment of normal healthy volunteers (NHV).

The Cypress Early Phase Research Unit is housed in a 75,000 square foot space and has 150 beds. The Costa Mesa unit has 30 semi-private rooms and can house up to 60 subjects in a 25,000 square foot facility. Unit capabilities and amenities include:

-Large open phlebotomy areas
-ECG rooms with multiple stations
-Semi-private subject rooms
-Multiple subject entertainment options (Direct TV, computers, internet, DVD players and movies, ping pong, Foosball, PlayStation 2, etc.)
-Two spacious PK sample lab processing areas
-Large and comfortable monitor stations with phones and high speed internet access
-Securely locked ambient and refrigerated drug storage room
-Two pharmacy dosing and storage areas with a study drug laminar flow hood
-Secure medical records and CRF storage rooms

WCCT is capable of providing full service studies including protocol writing, data management, biostatistics and medical writing either in-house or in combination with trusted service providers.

WCCT Global has multiple processing labs within each site. Our labs are fully equipped, temperature regulated ,and capable of safely processing a large number of pharmacokinetic, pharmacodynamic, and pharmacogenomic samples. Our lab is staffed by highly trained individuals capable of performing all tasks necessary to satisfy protocol requirements.
a. Equipment (ie: freezers, refrigerators, centrifuges, etc.):
i. 4 -80°C Freezers
ii. 3 -20°C Freezers
iii. 10 Temperature regulated centrifuges
iv. 2 sliding glass door refrigerators
v. Platelet Aggregometry Equipment
vi. Hematology Equipment
vii. Micro-pipettors
viii. Cell Processing Equipment
ix. Biological Safety Cabinet
x. Homogenization Equipment

Information coming soon.

The Early Phase Research unit’s equipment list includes: atomic clocks and watches for time synchronization, ten (10) refrigerated centrifuges, 12+ ECG Machines, four -80º C freezers, several -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, a platelet aggregometry lab and multiple spirometry units.
a. Vital sign machines
b. ECG Machines
c. Telemetry equipment
d. Calibrations and maintenance records for each equipment

The Cypress Screening Department is capable of screening up to 112 subjects per day and Costa Mesa early phase research unit can screen a maximum of 24 subjects per day. Both units have waiting rooms large enough to seat up to 40 and 20 volunteers, respectively. Cypress clinical back office area has 15 rooms and Costa Mesa has 8 rooms that are designated and equipped for consenting and for any study specific screening procedure (e.g. height & weight measurement, Vital signs, ECG, PE, and PFT). A crash cart is strategically located for any medical emergencies . The screening departments in both units also have a spacious lab area which are fully equipped to process routine safety lab samples.

Information coming soon.