Worldwide Clinical Trials Expands Clinical Pharmacology Unit
Upgrades include end-of-life equipment replacements and relocation.
Worldwide Clinical Trials has announced an expansion of the pharmacy at its Clinical Pharmacology Unit (CPU) in San Antonio, Texas, according to a company press release.1 In addition to equipment upgrades, expansion efforts focused on operational demand, workplace demand, and employee engagement with the overall goal of enhancing customer experience. Completed in January 2024, the expanded pharmacy provides customers with streamlined processes, as well as decreased timelines and costs.
“A common thread among our Worldwide team members is a passion to take care of our customers—we’re always looking for ways to improve our partnerships,” said Mike Mencer, executive vice president and general manager, early phase, Worldwide Clinical Trials in the press release. “As part of an ongoing $5 million upgrade to our CPU, this expansion aligns with our culture of quality and our dedication to continuous improvement and innovation to meet our customers’ growing needs as we work together to improve the lives of patients around the world.”
Worldwide’s CPU, a 200-bed, fit-for-purpose facility, has been in operation since 2005. Within the unit, studies are conducted in healthy volunteers, patients, and specialty populations. The CPU is conveniently located one hour from Worldwide’s Bioanalytical Center of Excellence, offering an approach that benefits customers through streamlined vendor management, consistent standards, technical expertise, and overall efficiencies such as sample transfer and rapid processing.
“Expanding our pharmacy in size enables us to expand in volume, providing additional opportunities and efficiencies for our customers,” said Lona Sheeran, senior vice president, clinical operations, early phase, Worldwide Clinical Trials in the press release. “We can now manufacture onsite, in real time, for Phase I studies per FDA guidance, allowing our customers the option to pivot on their dose while their study is ongoing. This service is unique and can save our customers thousands of dollars and months of time—a huge advantage in this fast-paced industry.”
Reference
- Worldwide Clinical Trials Expands Clinical Pharmacology Unit Pharmacy to Enhance Customer Experience; Adds Efficiencies and Decreases Timelines. News release. February 21, 2024. Accessed February 21, 2024. https://www.businesswire.com/news/home/20240221954891/en
FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research
May 21st 2025In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Full Phase IIIb BATURA Trial Results Show Airsupra Cuts Severe Exacerbations by 47% in Mild Asthma
May 20th 2025Results from the pivotal BATURA trial show that Airsupra (albuterol/budesonide) significantly outperformed albuterol monotherapy in reducing severe asthma exacerbations and systemic corticosteroid exposure, reinforcing its role as a next-generation, anti-inflammatory rescue therapy for mild asthma patients.
