WCCT Global has performed over 200 Phase I studies and more than 360 Phase II-IV trials across a very diverse client base, since its founding in 1998.

WCCT owns two Clinical Pharmacology Units (CPUs): a Phase I Unit in Cypress, CA and a Special Populations Unit in Costa Mesa, CA. Both units are located within two large metropolitan areas, strategically situated to recruit from a very diverse ethnic 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. With over 50,000 sq/ft of research space, 180 beds (if required), and a staff of ~200 qualified employees, WCCT’s CPUs are capable of addressing demand for a high volume of patients in a very short period of time.

 

WCCT Global has a longstanding successful history of rapid enrollment of volunteers into complicated, specialized trials as well as simple, bioequivalence/bioavailability studies.  Always exceeding Sponsors expectations along the way, we have been conducting clinical research since 1998.  Suffice it to say, we believe that with over 14 years of experience, WCCT is uniquely poised to address our Sponsor’s needs across the clinical research landscape.

To date, our clinical operations staff has completed over 2,200 trials in the past 30 years.  Our team carries a balanced study perspective, with experiences at the site, CRO, Pharmaceutical, and Data Management levels.  Many team members have worked as Study Coordinators before becoming Clinical Research Associates (CRAs), and still others have worked for Data Management companies before joining WCCT in a Project Management capacity.  This cross-functional experience provides value to our Sponsors.  Additionally, WCCT owns and operates two CPUs, giving us a unique study perspective because we understand the challenges that Phase I sites endure.  WCCT has a well-trained staff of coordinators who have successfully finished an intensive 10-week GCP focused training program.  We are a CRO that understands research from a site and patient/volunteer point of view.

 

Early Phase Development services (Phase I) include:

We provide individualized services, which can be requested on a stand alone basis or as part of an integrated “full-service” solution.

• Product development consulting
• Pharmacokinetic Data Analysis (TK, PK, PK/PD)
• Regulatory affairs strategy / submission
• Protocol design
• Medical Writing
• Subject Recruitment
• Quality Control/Assurance
• Clinical studies including:
  • Food effect studies
  • Dosage Regimen assessments
  • QTc studies
  • First in man, SAD/MAD dose escalation, PK/PD
  • Multiple dose studies
  • Drug interaction studies
  • Bioavailability, bioequivilence
  • Phase I patient studies
    • HCV
    • Allergy & Asthma
    • Ophthalmology
    • Respiratory
  • Special population studies
    • Asian Bridging Studies
    • Pediatrics
    • Renal & Hepatic Dysfunction
  • Proof of concept studies

Late Phase Development services (CRO) include:

• Clinical Operations
• Medical and Safety Services
• Data Management
• Biostatistics
• Clinical Development Support
• Scientific & Medical Communications

Our key CRO services include:

• Project Management of development programs
• Clinical trial and site management
• Clinical trial monitoring
• Patient recruitment
• Contract management and investigator reimbursement

 

The WCCT Global Anti-Infective/Anti-Viral/Vaccine Therapeutic Center of Excellence is comprised of a network of therapeutic experts who can provide the specialized knowledge required to address the unique challenges of developing anti-infectives.  We can provide guidance support for:

• Diagnoses and treatment of infectious diseases
• Currently available anti-infective drugs; their mode of action, efficacy and safety
• Specific risks of anti-infective drug development and how to manage them
• Specialized knowledge of clinical trial methodology and efficacy assessment methods
• Relationships with key opinion leaders
• Access to a well-established global network of investigators in infectious diseases, vaccines and public health

Our investigator database includes hundreds of anti-infective and vaccine investigative sites.