CAP Accreditation Underscores Early Phase Clinic’s Commitment to Exceptional
Standards in Safety, Quality, and Best Clinical Laboratory Practices
Research Triangle Park, N.C. – 14 September, 2023 – Worldwide Clinical Trials, a leading global, full-service contract research organization (CRO), has announced its Early Phase Clinical Pharmacology Unit (CPU) has been awarded accreditation from the College of American Pathologists (CAP). To achieve accreditation, the clinic passed a rigorous evaluation process that involved an in-depth inspection of its clinical laboratory facilities, equipment, processes, quality control measures, and personnel qualifications – conducted onsite by CAP inspectors.
“The College of American Pathologists is known for the highest standards in laboratory quality,” said Mike Mencer, Executive Vice President and General Manager, Early Phase. “The CAP Laboratory Accreditation Program provides a clear roadmap for running a high-quality clinical laboratory, with checklists updated annually to ensure we stay current with rapidly evolving advances in medicine, technology, and regulatory compliance as we partner with our customers to develop new medications and treatments. As the latest in our series of investments in facilities, capabilities, and certifications, this accreditation upholds our culture of quality and our commitment to provide customized services to every clinical research program we launch, while adhering to stringent regulatory requirements.”
Operating since 2005 and located in San Antonio, Texas, Worldwide’s CPU is a 200-bed, fit-for-purpose facility. Within this unit, studies are conducted in healthy volunteers, patients, and specialty populations. The CPU is located one hour from Worldwide’s Bioanalytical Center of Excellence, offering a comprehensive approach that benefits customers through streamlined vendor management, consistent standards, technical expertise, and overall efficiencies such as seamless sample transfer and rapid processing.
Worldwide opened the Bioanalytical Center of Excellence in June 2022 in Austin, Texas, to support its Early Phase development and expansion. The state-of-the-art, 57,000 square foot facility offers about 20 percent more usable space than the previous lab, and is outfitted with modern infrastructure, improved air control, and efficient lab space to flexibly support current and future early phase research demands while enabling optimized workflows to ensure critical customer timelines are met. The expansion also included the addition of large molecule capabilities and services, led by Dr. Tom Zhang, with a 15,000 square foot large molecule lab within the Bioanalytical Center of Excellence. With the addition of this large molecule dedicated lab, Worldwide positioned itself to meet and exceed the increasing demand within the large molecule bioanalytical testing services market.
About Worldwide Clinical Trials:
Worldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Our capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by our accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program.
Anchored in our company’s scientific heritage, we are therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic disorders. Our deep therapeutic knowledge and country-specific operational acumen enable us to develop flexible plans and quickly solve problems for our customers.
Our team of 3,200+ professionals spans 60+ countries, and believes that through a culture that embraces diversity, equity, inclusion, and belonging (DEI&B), everyone plays a vital role in making a world of difference for patients and their caregivers. We are united in cause with our customers to improve the lives of patients through new, innovative therapies.