Early Phase/Phase I Development
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:
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.
We are highly experienced in:
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:
We have experience supporting trials with these rare and specialty patient groups:
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.
We offer a range of early development contract research organization (CRO) services executed by professionals fully dedicated to early development.
These services include:
Make informed decisions, faster with Worldwide Clinical Trials’ Bioanalytical Laboratory