Nonclinical Efficacy Testing » Essential Information Before Requesting a Nonclinical Study » Comparing international outsourcing practices and model provision formats

Comparing international outsourcing practices and model provision formats

When using overseas CROs or disease models, the company's location alone does not allow you to determine the actual study execution country, contract terms, language, international transport, or regulatory compliance. Furthermore, the mere information that they "possess the model" does not tell you whether that model can be utilized for standard contract research.

Here, practical conditions regarding international outsourcing and each company's model provision formats are organized by item. Please use this as a reference checklist when comparing candidate outsourcing destinations.

Things to check before looking at the comparison table

The head office location and the test implementation country are different.

We will confirm the locations of the sales offices or Japanese legal entities separately from the locations of the facilities where the non-clinical studies are actually conducted.

The Japanese-language support desk and the availability of domestic contracts are separate items.

I will check separately whether we can consult in Japanese and whether the Japanese legal entity can be the contracting party.

Owning a model and conducting regular testing are different things.

Distinguish between proprietary models, routine implementation, past performance, partnership models, and custom builds.

Not listed does not mean unsupported

Items that cannot be confirmed through publicly available information alone are marked as "pending confirmation" and are not judged as unsupported.

Comparing Practical Conditions Required for International Outsourcing

When outsourcing to an overseas CRO, it is necessary to separately confirm the actual countries where the trials will be conducted, the Japanese-speaking point of contact, the contracting entity, the language of the reports, international shipping, and the scope of compliance with the regulations of each country.

You can scroll horizontally to view the table.

company Company type Headquarters location Actual test implementation countries and locations Availability of Japanese support desk Eligibility for contracting with domestic corporations Report language Handling international shipping Response to PMDA, FDA, EMA, etc. Verification source
Labcorp Global CRO / laboratory services United States US / China - Shanghai / UK - Germany, etc. Yes (Japanese website and Japanese branch information available) Please confirm Please confirm Global logistics system available. Individual conditions must be confirmed. Global non-clinical and regulatory submission support available. PMDA compliance scope must be confirmed individually. Verification source
Charles River Laboratories, Inc. Global CRO / research models United States US, Canada, China, Europe, Australia, etc. Please confirm Please confirm Please confirm Global support. Conditions for each project must be confirmed. Includes non-clinical development and regulatory compliance. Scope of coverage by region must be confirmed. Verification source
Crown Bioscience Oncology / metabolic disease CRO Global (with a Japanese subsidiary) Research facilities in Asia, Europe, and the United States Yes Japanese subsidiary exists. Contracting entity to be confirmed per project. Please confirm Handling international cases. Shipping conditions need to be confirmed. Drug discovery and non-clinical support available. Scope of regulatory application support needs to be confirmed. View company information
WuXi AppTec Global CRO / CDMO China overseas non-clinical facilities centered on China Available (Japanese subsidiary as the contact point) Case-by-case review Please confirm Handling international cases. Shipping terms to be confirmed per case. Integrated non-clinical support including IND-enabling View company information
Inotiv, Inc. Global CRO United States US, Europe, etc. Details need to be confirmed. Please confirm Please confirm Please confirm Please confirm Publishing support track record including IND/NDA/BLA, etc. View company information
Eurofins Discovery Discovery / preclinical CRO Global In-house labs in multiple countries. Check by service. Please confirm Please confirm Please confirm Please confirm Supporting from early drug discovery to preclinical stages. Regulatory compliance scope to be confirmed. View company information
Evotec SE Global discovery / preclinical CRO Germany, Hamburg Europe, US, etc. Check by service Please confirm Please confirm Please confirm Please confirm Supporting from drug discovery to preclinical development. Please confirm the scope of application support. View company information
Gubra A/S Specialty preclinical CRO / biotech Denmark our facility centered in Denmark Please confirm Please confirm Please confirm Please confirm Preclinical support in the metabolism and fibrosis therapeutic areas View company information
Biocytogen Boston Corp Model provider / CRO / biotech China, Beijing China-centric. Overseas implementation sites to be confirmed per project Please confirm Please confirm Please confirm International supply of models and samples available. Conditions are subject to confirmation. Promoting support from early drug discovery to IND View company information
SMC Laboratories Specialty Efficacy CRO Japan, Tokyo Japan (LA Office is the point of contact) Yes Contracts with domestic corporations are accepted. Japanese and English will be verified per project. Overseas customer projects, international shipping available. Conditions need to be confirmed. Focused mainly on pharmacodynamics and pharmacology. The scope of regulatory submission support needs to be confirmed. Verification source

The "actual test execution countries" are organized by prioritizing the location of facilities where non-clinical, pharmacology, toxicology, DMPK, etc., are conducted, rather than the business offices.

Comparison of Disease Model Delivery Formats

The use of disease models is not limited to cases where each company uses its own uniquely developed model. Other approaches include conducting studies as standard contract menus, using partner-affiliated models, and newly building models for each project.

proprietary model

This model is developed, branded, and copyrighted in-house.

regularly implemented at our own facilities

This is a model that includes standard procedures and can be undertaken as a routine project.

Past implementation experience

While there is a past track record, it is not necessarily offered on a regular basis currently.

Via license and partners

We will use external models, licenses, and partner technologies.

Custom-built for each project

We newly construct or optimize models depending on the target and pathological conditions.

You can scroll horizontally to view the table.

company proprietary model Regularly conducted at our own facilities Past implementation experience Implemented through licenses and partnerships Custom-built for each project Notes on Comparison
Labcorp Please confirm Public information available Please confirm Please confirm Verify individually for each case We will check the Japanese base and the actual testing site separately.
Charles River Laboratories, Inc. Please confirm Public information available Publicly available information and proven track record Publicly available / Requires confirmation Custom options available / Details require confirmation We will check the model supply business and contract testing separately.
Crown Bioscience Available (HuGEMM™, HuCELL™, etc.) Yes Yes Yes / Individual confirmation Yes / Individual confirmation We check proprietary models, humanized models, PDX, etc., on a model-by-model basis.
WuXi AppTec Please confirm Yes Yes Please confirm Available / Requires confirmation We will check the contact point function of the Japanese subsidiary and the actual testing facility separately.
Inotiv, Inc. Please confirm Public information available Publicly available information and proven track record Please confirm Please confirm Evaluating toxicity, DMPK, and efficacy at the facility level increases accuracy.
Eurofins Discovery Please confirm Public information available Publicly available information and proven track record Please confirm Please confirm We will examine the in vitro assay and the in vivo disease model separately.
Evotec SE Please confirm Public information available Publicly available information and proven track record Please confirm Custom options available / Details require confirmation We will also check separately whether it is an integrated drug discovery program-type contract.
Gubra A/S Present (custom disease model) Yes Yes Please confirm Please confirm Specialized in MASH, obesity, diabetes, fibrosis, etc.
Biocytogen Boston Corp Yes (such as BioMice) Yes Yes Licensing and partnership options available Custom gene modifications, etc. included I will check the model sales and the commissioned testing using that model separately.
SMC Laboratories Yes (STAM™, STAM™-HCC / IO+, etc.) Yes Yes Yes (PXB-mouse®, etc.) Available (Made-to-Order Model) You can clearly check and distinguish between proprietary, partnered, and custom-built options.

Yes relatively clearPublic information available There is a difference in the granularity of information.Please confirm Do not make definitive conclusions based solely on publicly available information.

Regarding the published information

This page organizes comparison items based on publicly available information. Items marked as "Needs Confirmation" or left unlisted do not imply that a company does not support them. Test details, implementing facilities, contract terms, languages, transportation, regulatory compliance, and model availability are subject to change. Please check official information or contact points of each company for specific outsourcing terms.

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
SMC Laboratories, Inc.
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
Charles River Laboratories
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
Inotiv
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.

By Therapeutic Area
Disease Animal Models
and Reviews
Proven Capability, Expertise and Track Record
Top 3 Non-Clinical CRO Services