Early Phase – Phase I / Clinical Pharmacology Services
With the ever-increasing complexity of Phase I trials, Worldwide has you covered.
Accelerate Your Molecules’ Success with Worldwide Clinical Trials.
Operating since 2005, Worldwide’s CPU in San Antonio, TX, is a 200-bed, fit-for-purpose facility. Within this unit, studies are conducted in healthy volunteers, patients, and specialty populations. Our volunteer database spans a broad range of specialized populations, including overweight/obese, post-menopausal/surgically sterile females, healthy elderly, renal impairment, hepatic impairment, metabolic syndrome, T2DM, dyslipidemias, and NASH.
Comprehensive Support Services for Phase I
We offer a range of early phase contract research organization (CRO) services executed by professionals fully dedicated to your early development program. These services include:
Medical and Scientific Consultation
- Concept and Regulatory Approach
- Protocol Design
- Program Development
Regulatory
- Pre-IND/IND Services
- Ethics Review Board Submission
Scientific and Medical Writing
- Protocols and Synopsis
- Informed Consent Document
- Clinical Study Reports
Clinical Conduct
- Worldwide CPU Site
- QA Approved Phase I Global Site Network
- Recruitment of Healthy and Patient Populations
Clinical and Medical Oversight
- Medical Monitoring
- Clinical Monitoring
- Pharmacovigilance
Project Management
- Oversees All Aspects of Study Execution
- Tracks Progress, Costs, and Timelines
- Multi-site Feasibility and Management
- Directs Project Communication
Data Management and Biostatistics
- Phase I Focus and Expertise
- Dedicated Phase I Teams
Pharmacokinetic Team
- PK/PD/Tox Analysis and Reports
- Consultation Service
Clinical Pharmacology Unit
- 200-bed, highly flexible, fit-for-purpose clinical pharmacology unit in San Antonio, Texas
- A high complexity CLIA accredited clinical safety lab providing rapid turnaround of test results (screening and safety)
- On-site cGMP Phase I compounding pharmacy service, allowing for accelerated timelines due to rapid investigational medicinal product (IMP) preparation
- Full suite of clinical pharmacology studies
- One hour travel time by courier to our bioanalytical lab (GLP) for timely sample analysis
Our Dedicated Team
Dr. Sherilyn Adcock
Chief Scientific Officer, Early Phase Development
Our industry thought leaders and seasoned professionals are ready to consult and advise your next project to optimize data and give you the competitive advantage you deserve. Meet a few of our team members.
Lona Sheeran
Senior Vice President, Clinical Operations Early Phase
Mike Mencer
Executive Vice President and General Manager, Early Phase
Marie T. Simerly, PMP
Senior Director, Project Management Early Phase
Olutola O Adetona, MD, MPH, CPI
Medical Director/Certified Principal Investigator – Early Phase Clinical Operations
Phase I Resources
We are here to help with your next project.
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