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 drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D. In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening. Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.

Pharmacology (Efficacy) Studies
Replicate unknown pathological models and
Discovery to clinically oriented drug evaluation
SMC Laboratories, Inc.
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)
  • SMC Laboratories, Inc. has established a disease models using patented mouse technologies. The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
  • From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project. Their collaborative approach allows researchers to discuss and refine study plans together with SMC’s expert scientists.
  • With flexible small-scale study options and strong technical support, SMC Laboratories, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.
Safety Studies
Comprehensive Safety Evaluation for FIH Applications
Labcorp Holdings Inc.
(Labcorp Drug Development)
Labcorp Holdings Inc.
Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)
  • Labcorp Holdings Inc. provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements. All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
  • The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
  • Labcorp Holdings Inc.’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials. For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.
Pharmacokinetic (PK/PD) Studies
High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation
PhoenixBio Co., Ltd.
PhoenixBio Co., Ltd.
Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)
  • PhoenixBio Co., Ltd. offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to–drug interaction studies, bridging the gap between preclinical and clinical stages.
  • With advanced LC-MS/MS-based bioanalysis, PhoenixBio Co., Ltd. provides a seamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.
  • The company offers an integrated evaluation analysis covering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics. For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio Co., Ltd. delivers unmatched analytical precision and consistency.
By Therapeutic Area
Disease Animal Models
and Reviews
Proven Capability, Expertise and Track Record
Top 3 Non-Clinical CRO Services