Our Full-Service Clinical Research Unit

Established in 2005, Worldwide’s Clinical Research Unit in San Antonio, TX, has 300 beds and conducts over 100 studies in healthy volunteers, patients, and specialty populations each year. The unit offers an on-site cGMP Phase 1 compounding pharmacy service, CLIA safety testing, and local PK bioanalytical validation and GLP testing.

Clinical Pharmacology Studies

We are highly experienced in:

  • First-in-Human Single Ascending Dose/Multiple Ascending Dose
  • Drug-Drug Interaction
  • QT Cardiac Safety
  • Food Effect
  • PK/PD
  • Bioequivalence
  • Bioavailability
  • Human AME Studies

Special Procedures

  • Serial and Continuous Cerebral-Spinal Fluid (CSF) Collection
  • CNS Cognitive Evaluation
  • Inhalation/Intranasal Delivery
  • Intratympanic Injection
  • Drug-Alcohol Interaction
  • Female OC-Drug Interaction

Patient and Special Populations

  • Impaired Renal/Hepatic Function
  • Healthy Elderly
  • Metabolic Syndrome
  • Adolescent
  • Low Testosterone
  • Post-menopausal

We also have a network of partner sites that provide solutions for additional patient populations.

State-of-the-Art Facility

  • Limited-access Phase I unit
    • Flexible procedure areas based on study design
  • cGMP Phase I pharmacy
    • Class 10,000 clean room
    • Federal and state Schedule I-V drug licensure
  • Full-service clinical laboratory
  • Fully equipped sample processing laboratory
  • Security-alarmed -70°C and -20°C freezers
  • Telemetry equipment
  • Centralized atomic clock system

The site offers limited access Phase I and telemetry units and is certified under the Clinical Laboratory Improvement Amendments (CLIA). It has adaptable procedure spaces and a fully equipped sample processing lab that delivered 600,000 samples in a recent year. In addition, the pharmacokinetics lab features 14 centrifuges and handles more than 300,000 samples per year.

Within the facility is a 1,200 square-foot pharmacy with an ISO Class 7 clean room and ISO Class 5 laminar flow hood. The pharmacy operates under GCP, USP 797, and FDA cGMP Guidance for Phase I investigational drugs. Its compounding suite houses analytical balances with capabilities as low as 2 mg.