- Concept and Regulatory Approach
- Protocol Design
- Program Development
Phase I and Clinical Pharmacology Services
With the ever-increasing complexity of Phase I trials, we have you covered.
Learn about our Phase I services
Discover the Worldwide Difference
We specialize in designing and executing customized studies that drive your drug development forward. Our Phase I and clinical pharmacology services are tailored to meet the specific needs of your program, whether it’s a challenging study design or a unique objective.
Our commitment starts with our first conversation and lasts throughout our entire working relationship. You’ll see it in the dedication of our staff, the flexibility and availability of our leadership team, and the services you receive.
It is our mission to deliver quality data faster, allowing your asset to accelerate to the next step.
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Sponsor Audit Pass Rate
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Bed, Highly Flexible, Fit-for-Purpose Clinical Research Unit
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Dose Full On-Time
Learn more about who we are and how we’d approach your study
Comprehensive Support for Every Step of Your Clinical Journey
No two studies are the same, and neither are their paths to success. We’re committed to offering bespoke support at every stage of your clinical development journey.
Medical / Scientific Consultation
Phase I Clinical Conduct
- Worldwide CPU Site
- QA Approved Phase I Global Site Network
- Recruitment of Healthy Patient Populations
Bioanalytical Sample Collection Services
- Customizable PK and PD collection kits and bulk supplies
- Kits supplied with labeled tubes on a per-visit basis
- Training materials included as part of kits
Bioanalytical Lab in Austin, Texas
- GLP and Part 11 Compliant; Support Regulated Bioanalysis (Clinical Studies, GCP)
- Small and Large Molecule Bioanalysis, Pharmacokinetic Analysis and Reports
- DEA and RAD-licensed
Full Suite of Clinical Pharmacology Studies
- First-in-Human
- Integrated SAD and MAD (includes FE/DDI/BA/EPQT)
- Drug-Drug Interaction
- BE/BA
- Food and Meal Timing Effect
- PK/PD
- AME/Mass Balance/Metabolite Profiling
- Renal Impairment
- Hepatic Impairment
- Expert Precision QT and Thorough QT Evaluations Impairment
- POC Studies in Patients
- CSF Collection and Analysis
- Specialty Procedures (Biopsies, NG tube, and unique routes of administration)
Pharmacokinetics / Pharmacodynamics
- PK/PD/Tox Analysis and Reports
- Consultation Services
Data Management / Biostatistics
- Phase I Focus and Expertise
- Dedicated Phase I Teams
Scientific and Medical Report Writing
- Protocols and Synopsis
- Informed Consent Document
- Clinical Study Reports
Clinical Pharmacology Unit
Our 200-bed, highly flexible, fit-for-purpose clinical pharmacology unit in San Antonio, Texas, includes the following to accommodate your study’s needs:
- Class 10,000 clean room (USP Chapter 797 compliant)
- Experience in managing Schedule I-V controlled substances
- Study Specific Dose Preparation services
- HEPA filtration system in both sterile and non-sterile areas
- Temperature and humidity monitoring
- Capable of handling light-sensitive products
- Dedicated radiolabel preparation area
- Full-time RSO and contract physician oversight for AME
- Dedicated team
- Standard laboratory testing on site, with expansion capabilities as needed
- Fully validated eSource data collection system
- Clinical Chemistry
- Hematology
- Serology
- Urinalysis Dipstick with Microscopy
- Urine Drug Screen
- Coagulation testing — PT / INR and Partial thromboplastin time
- COVID testing
- RT – PCR via Cephid machine
- Filtering of plasma
- Homogenized samples
- Processing of high sample volumes
We’re here to help you succeed
WorldwideEdge™
We know our people, processes, and technologies can play a key role in your asset’s success. This understanding is at the heart of our continuous innovation initiative—WorldwideEdge™.
Award-Winning Phase I Services
Clinical Leader announced the 2024 Leadership Awards, supported by data from ISR Reports, naming Worldwide Clinical Trials the highest-rated Phase I Service Provider for Overall User Preference and the highest-rated Phase I Service Provider for Data Management.
A Tailored Program, Every Time
We understand that no two Phase I trials are the same. That’s why we offer flexible, customized solutions through our state-of-the-art bioanalytical laboratory, full-service, fit-for-purpose clinical pharmacology unit, and specialized pharmacy services. With an unwavering commitment to excellence, we deliver high-quality data faster, ensuring your asset progresses seamlessly to the next phase without compromise.
See what our clients have to say
Our Dedicated Phase I Experts
Validated Assays
Worldwide Clinical Trials has access to more than 2,000 validated assays.
See what Worldwide Clinical Trials can do for you.
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