CLINICAL PHARMACOLOGY UNIT IN SAN ANTONIO, TX

OUR FULL-SERVICE FIT-FOR-PURPOSE CLINICAL PHARMACOLOGY RESEARCH UNIT

Your early phase clinical development needs a clinical pharmacology unit (CPU) that’s renowned for its services, staff, and accessibility. Worldwide Clinical Trials has been top-ranked by its early phase customers for these qualities in the latest Early Phase CRO Quality Benchmarking Report by Industry Standard Research, making it the go-to CRO for your early phase program.

Established in 2005, Worldwide’s Clinical Research Unit in San Antonio, TX, is a 200-bed, highly flexible, fit-for-purpose clinical pharmacology unit. Within this unit, more than 100 studies in healthy volunteers, patients, and specialty populations are conducted each year. The patient database capabilities span a broad range of specialized populations, including CNS, cardiovascular, and metabolic patient populations. The Worldwide unit has several distinct differentiating capabilities, including:

• An on-site cGMP Phase 1 compounding pharmacy service, allowing for accelerated timelines due to rapid investigational medicinal product (IMP) preparation
• CLIA safety testing providing rapid turnaround of test results (screening and safety)
• Local pharmacokinetic bioanalytical validation and Good Laboratory Practices (GLP) testing for studies requiring time-sensitive bioanalytical assay preparation following sample collection

A STATE-OF-THE-ART FACILITY FOR YOUR PROGRAM

• 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 has successfully delivered 600,000 samples in a 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.

CLINICAL PHARMACOLOGY STUDY EXPERIENCE

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
• AME studies (radiolabeling)
• Renal/hepatic-impaired patient populations

CLIENTS CHOOSE WORLDWIDE FOR ITS SPECIALIZED CLINICAL PHARMACOLOGY PROCEDURES

When you require a CRO partner with uncommon experience, look no further than Worldwide Clinical Trials. Our staff is trained to handle specialty clinical pharmacology procedures, including:

• Serial and continuous cerebrospinal fluid (CSF) collection
• CNS cognitive evaluation
• Inhalation/intranasal delivery
• Intratympanic injection
• Drug-alcohol interaction
• Female OC-drug interaction
• Respiratory dose administration

WORLDWIDE CAN SUPPORT YOUR PATIENT AND SPECIAL POPULATIONS

We have experience supporting trials with these rare and specialty patient groups:

• Impaired renal/hepatic function
• Healthy elderly
• Metabolic syndrome
• Adolescent
• Low testosterone
• Post-menopausal
• NASH/NAFLD

We also have a network of partner sites that provide solutions for additional patient populations. Ready to take a deeper dive into our experience with patient populations? Learn more now.

OFFERING FULL-SERVICE EARLY PHASE PROGRAM SUPPORT

We offer a range of early development contract research organization (CRO) services executed by professionals fully dedicated to early development.

These services include:

• Protocol design and early phase concept and program development
• Protocol writing
• Regulatory and pre-IND/IND meeting consultation services
• Scientific consultation
• Multi-site feasibility support based upon established QA-approved site network
• Dedicated Phase I/early development project management group
• Phase 1 focused data management
• Biostatistics and statistical design planning specific to early development studies
• Pharmacokinetics
• Clinical monitoring
• Pharmacovigilance
• Site management
• Medical writing