Crown Bioscience, a global contract research organization (CRO) headquartered in the United States and part of JSR Life Sciences and Japan-based JSR Corporation, announced today that its San Diego laboratory has received Clinical Laboratory Improvement Amendments (CLIA) certification. This significant milestone enables Crown Bioscience to deliver clinical-grade testing, further strengthening its support for clients' clinical and translational drug development efforts.
CLIA, regulated by the Centers for Medicare and Medicaid Services (CMS), sets rigorous federal standards for accuracy, reliability, and quality laboratory operations. With this designation, Crown Bioscience’s San Diego facility affirms full compliance, providing clients with increased confidence in the biomarker data used for clinical decision-making and regulatory submissions.
"Achieving this marks a crucial step in our commitment to delivering high-quality, compliant laboratory services," said Julie Mayer, Vice President, Global Biomarker Platform at Crown Bioscience. "This enables us to expand our offerings by leveraging CLIA certification to support our partners in accelerating their clinical development and regulatory approval timelines."
As a CLIA-certified laboratory, Crown Bioscience is now equipped to conduct clinical testing on human specimens, a key component of advancing oncology research and personalized medicine. This designation strengthens the company’s position as a trusted partner capable of meeting specialized project needs throughout all stages of drug development.
For more information about Crown Bioscience’s certifications and accreditations, please visit the company’s website.
About Crown Bioscience
Crown Bioscience, a JSR Life Sciences company, is a global contract research organization (CRO) dedicated to accelerating drug discovery and development in oncology and immuno-oncology. We partner with biotech and pharmaceutical companies to provide innovative, tailored solutions spanning preclinical research, translational platforms, and clinical trial support. With the world’s largest commercially available patient-derived xenograft (PDX) collection and approximately 1,000 tumor organoid models powered by Hubrecht Organoid Technology, we offer unparalleled insights across 35 cancer indications. Our expertise spans in vivo, in vitro, ex vivo, and in silico methods, complemented by advanced laboratory services that span the entire drug development continuum. Additionally, our extensive biobank of liquid and human biospecimens, complete with clinical histories, enhances oncology research capabilities. Operating from 11 state-of-the-art facilities across the US, Europe, and APAC, our laboratories meet the highest industry standards, including accreditation by the College of American Pathologists (CAP) and the International Organization for Standardization (ISO). To learn more, visit www.crownbio.com.
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