WCCT Global

Company Overview

WCCT Global is a multisite, full-service pharmaceutical contract research organization (CRO) of outsourced early drug development and late phase CRO services to the pharmaceutical, biotechnology and medical device industries. We are the specialized global drug development professionals who offer an innovative, agile and collaborative approach to every program we deliver.

Our Mission: To advance global health by transforming clinical research.

Contact Information

Salvador Solis
Digital Marketing Manager
WCCT Global
3545 Howard Way
Costa Mesa, CA 92626
USA
(657) 229-6907
(714) 252-0799 (fax)
mgr@wcct.com
www.wcct.com
View Map

CRO Services

Study Design
  • Site feasibility studies
  • Identification
  • Qualification
  • Management
  • Contracting payment
  • Budget negotiation
  • Ethics committee approvals
  • Investigator meeting

    Study Start-Up

  • Protocol design
  • Clinical development plan design
  • Commercialization plan
  • Regulatory approach
  • Country and site selection
  • Protocol optimization

    Study Management

  • Internal and external team management
  • IND gap analysis
  • Vendor management
  • Timeline management
  • Budget management
  • Project reporting
  • Risk management

    Pharmacovigilance

  • Consulting
  • 300-person medical call center to handle AEs
  • SOP development
  • Safety plan development
  • Receipt and processing of SAE/SADE and AE/ADE reports
  • AE/SAE reconciliation
  • Literature review, including periodic line reporting (DSURs, PSURs/PBRERs and PADERs)
  • Safety database
  • Safety management plan
  • Signal detection and analysis
  • DMC, SRC, and IDSMB creation and maintenance
  • Aggregate analysis and support for safety review committees
  • Case narratives
  • Expedited reporting (IND safety reports, SUSARs, medical device and post-marketing reports)
  • Drug safety reporting to regulatory authorities, EudraVigilance, IRBs/IECs and investigators
  • Site, team and reporter training

    Project & Clinical Data Management

  • Development of the clinical data management plan (DMP)
  • Database design
  • Data validation plan preparation
  • CRF/eCRF design
  • Data entry of CRFs (paper system)
  • Data review
  • Data queries generation, tracking and reconciliation
  • Coding dictionaries generation for AEs (MedDRA) and medications (WHO Drug), and AE and medication data coding
  • Data reconciliation
  • Data transfer specifications
  • Interim analysis
  • Database lock

    Adaptive Trials

  • Faster go/no-go decisions
  • Risk mitigation
  • Increased safety by stopping ineffective or unsafe drugs
  • The ability to more quickly determine the optimal dose and frequency
  • Reduced costs due to fewer patients
  • Reduced time to market from combining proof-of-concept trials with dose-finding trials, or by combining dose-finding trials with confirmatory trials

    Study Rescue

  • Review and assessment of all study elements
  • Identification of key issues preventing study success
  • Trial rescue plan focused on resolving current bottlenecks and study challenges
  • Expedited study schedule to get it back on track
  • Complete solution to regain lost time and momentum

    Patient Recruitment

  • Cloud-based retention application
  • Social media targeting
  • Patient identification system
  • Branding and ad creation
  • SMS follow-up
  • Email marketing
  • Physician relations team
  • 24/7 call center
  • SEO services
  • Website development
  • Mobile-friendly patient sign-up application
  • Clinical Support Services

    Medical Writing
  • Clinical study protocol and amendments
  • Investigator’s brochure
  • Informed consent
  • Clinical study report (CSR)
  • Patient narratives
  • IMPD, eCTD and regulatory briefing documents
  • Integrated summary of safety/efficacy
  • Case report forms
  • Pre-IND packages
  • IND submissions/FDA meeting notes
  • Annual and final study reports
  • NDAs
  • BLAs and PMAs
  • Product assessments
  • Gap analyses
  • Medical alert letters

    Data Management

  • Clinical data management plan development
  • Database design
  • Data validation plan preparation (edit check specifications)
  • CRF/eCRF design
  • CRF data entry (paper system)
  • Data review
  • Data query generating/tracking/reconciling
  • Coding dictionaries for AEs (MedDRA) and medications (WHO Drug), and data coding of all AEs and medications
  • Data transfer specifications
  • Interim analysis
  • Database locking
  • Final datasets transfer to biostatistician

    Regulatory Affairs

  • Investigational new drug applications (INDs)
  • Investigational device exemptions (IDEs)
  • Pre-Market approval applications
  • Traditional and abbreviated NDAs
  • Chemistry, manufacturing and controls (CMC) Sections
  • 505(b)(2) applications
  • Drug, device and biologic master files – domestic and foreign

    Biostatistics

  • Discussion with regulatory agencies, including study design/analysis questions from regulatory agencies worldwide
  • Study design assistance during protocol development, including study objectives clarification
  • SAS programming and analysis
  • Sample-size/power calculation to increase likelihood of meeting objective within regulatory framework
  • Preparation of statistical analysis plan (SAP) to detail the statistical methodology and analytical plans
  • CDISC-compliant datasets (e.g., SDTM and AdaM)
  • Generation of statistical outputs for CSRs, DMCs and periodic safety documents
  • Results and methodology sections of the clinical study report
  • Integrated documents for submission
  • Clinical Pharmacology Unit Services

    Sites
  • One Phase I CPU certified as an American Heart Association training site
  • One Phase I-IV CPU distinguished as the first and only government-approved U.S. commercial facility capable of conducting an influenza clinical studies
  • One asthma and allergy clinic
  • Two ophthalmology and cosmetology research sites
  • Multiple gastroenterology research sites and outpatient center

    Ethnobridging

  • A single study once the target doses for the global trial have been identified in the U.S.
  • Adding Asian subjects to the first-in-human (FIH) study in the U.S.

    Vaccines and Influenza

  • 30 individual private rooms
  • Separate HVAC systems for controlled ventilation
  • Separate dedicated units for virus and vaccine storage
  • Owns the only challenge virus A/California/2009 (H1N1) in the U.S.
  • All staff are IATA certified and trained to process a wide range of samples
  • Diagnostic tests for influenza, including rapid antigen or PCR via nasal swabs or washed. The methodology to be implemented will be determined by the sponsor’s requirements.
  • The only PBMC-certified vaccine site

    Patient Outreach

  • Online clinical trial advertising such as engaging study branding
  • Targeted social media outreach
  • Search engine marketing with community outreach
  • Event sponsorships
  • Informational speeches and presentations
  • Therapeutic Expertise

  • Cardiovascular
  • Gastrointestinal
  • Infectious Disease and Vaccines
  • Oncology
  • Ophthalmology
  • Respiratory
  • Immunology and Allergy
  • CNS
  • Hepatitis C
  • Pediatrics
  • NASH
  • Other Information

    If you are interested in any of WCCT Global’s sites or services, please call (657) 229-6907 or e-mail mgr@wcct.com

    Contact Information

    Salvador Solis
    Digital Marketing Manager
    WCCT Global
    3545 Howard Way
    Costa Mesa, CA 92626
    USA
    (657) 229-6907
    (714) 252-0799 (fax)
    mgr@wcct.com
    www.wcct.com
    View Map

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