(Gaithersburg, MD) – July 23, 2020 – Smithers, a leading provider of testing, consulting, information, and compliance services, is pleased to announce it received a certification of compliance from the Clinical Laboratory Improvement Amendments (CLIA) program regulated by the Centers for Medicare and Medicaid Services (CMS) for its Ewing, New Jersey pharmaceutical development facility. Now, all of the Smithers U.S. pharmaceutical development laboratories are CLIA-certified, expanding its ability to perform testing that is subject to CLIA oversight.
The CLIA certificate enables Smithers to provide patient-specific data that will help its clients make pivotal decisions regarding drug safety, inclusion / exclusion criteria, and dosing during clinical trials. With this certification, Smithers is able to perform lab-developed tests in the diagnostic immunology and hematology specialties, such as anti-drug-antibody (ADAs), neutralizing antibodies (NAb), pharmacokinetics (PK), and biomarker assays that are deemed “high complexity” and subject to CLIA oversight.
“Our Gaithersburg, Maryland lab is CLIA-certified. With the addition of the Ewing, New Jersey lab certification, we are excited to expand our translational medicine services to this facility,” said Ira DuBey, PhD, President, Pharmaceutical Development Services. “Our clients’ needs are increasing in this area, and we are growing our capabilities to continue to meet their needs.”
The Pharmaceutical Development Services division is a specialized, bioanalytical contract research organization (CRO), which provides a comprehensive range of services from discovery through phase IV for the development of large-molecule therapeutics. Smithers has two labs in the United States, located in Gaithersburg, Maryland and Ewing, New Jersey, dedicated to pharmaceutical development.
Smithers continues to invest in talent, technology, and quality assurance to better serve its clients and grow its market share in the life sciences industries, which include pharmaceutical, medical device, and environmental sciences.