Crown Bioscience, a global contract research organization (CRO) headquartered in the United States and part of JSR Life Sciences and Japan-based JSR Corporation, today announced that its Suzhou, China laboratory has received Clinical Laboratory Improvement Amendments (CLIA) certification.
This achievement marks the company’s second CLIA certification in 2025, following its San Diego facility earlier this year, underscoring Crown Bioscience’s continued commitment to expanding its global network of compliant, clinical-grade laboratories.
Regulated by the Centers for Medicare and Medicaid Services (CMS), CLIA certification sets the highest federal standards for laboratory accuracy, reliability, and quality. The designation affirms that Crown Bioscience’s Suzhou laboratory meets all required compliance benchmarks, providing clients with greater confidence in the biomarker data that supports their clinical development and regulatory submissions.
‘’Earning a second CLIA certification within the same year reflects our global dedication to operational excellence and scientific integrity,” said Maria Radino, Vice President, Global Quality and Regulatory Compliance at Crown Bioscience. “With CLIA-certified laboratories in both the United States and China, we can now deliver consistent, regulated biomarker services across continents, accelerating translational research and advancing our clients’ therapeutic pipelines.’’
Building on its existing ISO 15189 accreditation, which demonstrates adherence to internationally recognized standards for medical laboratory quality and competence, this latest certification further strengthens Crown Bioscience’s regulatory portfolio. The Suzhou laboratory is now authorized to conduct clinical testing on human specimens, supporting oncology and immuno-oncology programs through high-quality biomarker analysis across its CLIA- and ISO 15189-accredited operations worldwide.
For more information about Crown Bioscience’s certifications and accreditations, please visit www.crownbio.com.
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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