Crown Bioscience, Inc. is an oncology-focused contract research organization headquartered in San Diego, California, founded in 2006.[S2] The company offers collections of patient-derived xenograft and organoid models. Its ownership has changed: it was a wholly owned subsidiary of Crown Bioscience International, listed in Taiwan, before JSR Corporation of Japan announced a merger agreement in December 2017 that the company states completed in 2018, after which the Taiwan listing ended.[S8] This profile summarizes the models, US sites, stated compliance information, and company facts most relevant to US sponsors.
Models and services
The oncology offering covers in vivo tumor models including patient-derived xenografts, cell line-derived xenografts and syngeneic models, immuno-oncology work and organoid platforms.[S4] Model counts differ between pages: the homepage cites more than 2,500 patient-derived xenograft models[S1] while the dedicated model page cites more than 3,000.[S3] Both are reproduced here as published. On the pharmacokinetics side, the DMPK service page describes its work as non-GLP.[S5]
US sites and where work runs
The company lists US sites in San Diego, California; Kannapolis, North Carolina; and Frederick, Maryland, the last acquired with Indivumed in 2023, alongside operations in China, the United Kingdom and the Netherlands.[S7] Which studies run at which site is not set out on the pages reviewed. For a US sponsor that distinction affects study monitoring, sample and data transfer and inspection exposure, so it is worth settling in the proposal rather than assuming that a US-headquartered organization runs every study in the United States.
Quality, compliance, and animal welfare (as stated by the company)
What the company does state. Its quality page lists CLIA certification obtained in July 2025 for the San Diego laboratory, College of American Pathologists accreditation obtained in January 2026, and ISO 9001 and ISO 15189 certifications.[S6] These certifications are separate from the good laboratory practice regulation that applies to nonclinical safety studies.
What was not found. Across roughly twenty pages reviewed for this profile, no AAALAC accreditation, OLAW Animal Welfare Assurance, Institutional Animal Care and Use Committee statement or GLP claim was found. The only GLP-related statement is the description of DMPK work as non-GLP.[S5] USDA appears only in a press release from 2016. For an organization whose core offering is in vivo tumor models in mice, the absence of current animal welfare statements on its public pages is a gap a sponsor should close by asking directly, particularly where the study site may be outside the United States. The company's website does not name a specific GLP regulation (FDA 21 CFR Part 58, EPA 40 CFR Part 160/792, or OECD GLP) for its facilities.[S5] GLP compliance is determined study by study under the applicable regulation, so sponsors should confirm in the protocol which regulation their study will follow and that the final report will carry the study director's compliance statement and the quality assurance unit's statement.[R2] AAALAC International accreditation is a voluntary evaluation of an institution's animal care and use program, re-evaluated every three years,[R3] and USDA registration and an OLAW Animal Welfare Assurance relate to the Animal Welfare Act and the PHS Policy respectively;[R4][R5] none of these establishes GLP compliance, which applies to individual studies.[R2] FDA does not approve or certify laboratories; registration with FDA does not denote approval.[R6]
The company states that its acquisition by JSR Corporation was completed in 2018. JSR announced a merger agreement in December 2017 which the company states completed in 2018; the previous Taiwan listing (TWSE: 6554) ended[S8]
US sites
San Diego CA; Kannapolis NC; Frederick MD (acquired with Indivumed in 2023)[S7]
Patient-derived xenografts cited as more than 2,500 on the homepage and more than 3,000 on the model page; also CDX, syngeneic and organoid models[S1][S3][S4]
FDA — "Is It Really FDA Approved?" (FDA does not approve health care providers, including laboratories; registration does not denote approval); FDA Compliance Program 7348.808 (GLP inspections of nonclinical laboratories). https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (accessed 2026-09-03)
3 Recommended Contract Research Organizations
for Non-Clinical Studies
— by Target goal and Expertise
In non-clinical development, the choice of contract research organization shapes the quality of the data and the time it takes to reach the next decision. Below, three CROs are introduced by the type of study they support: pharmacology (efficacy) studies, safety studies, and pharmacokinetic (PK/PD) studies. Each summary describes the services the company offers so that you can match a provider to your target and development objective.
Pharmacology (Efficacy) StudiesDisease-Relevant Models for Translational Drug Evaluation
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/)
SMC Laboratories, Inc.
SMC Laboratories is a specialized non-clinical CRO focused on in vivo pharmacology and efficacy studies using disease-relevant animal models, particularly in fibrosis, inflammation, metabolic diseases, and oncology.
Areas of Expertise
Disease-Relevant Model Portfolio
SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.
Study Design Based on Target Biology
Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.
Support from Target Validation to Proof of Concept
With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.
Safety StudiesComprehensive Safety Assessment for Preclinical Development
Reference: Charles River Laboratories official website (https://www.criver.com/)
Charles River Laboratories
Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.
Areas of Expertise
General Toxicology Across Study Designs
Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.
Non-GLP and GLP Study Support
Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.
Integrated IND-Enabling Safety Assessment
Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.
Pharmacokinetic (PK/PD) StudiesConnecting Drug Exposure with Pharmacological Response
Reference: Inotiv official website (https://www.inotiv.com/)
Inotiv
Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.
Areas of Expertise
Pharmacokinetic Characterization
PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.
Exposure–Response Evaluation
Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.
Integrated DMPK and Development Support
Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.
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