Nonclinical Efficacy Testing » Non-Clinical CROs and Agencies » CLEA Japan, Inc.

CLEA Japan, Inc.

Table of Contents
Table of Contents

Nippon Crea is a main supplier of laboratory animals, as well as a non-clinical CRO. Various disease models are available.

The company has established an integrated in-house platform for animal quality control and testing. They have a wide range of client bases for research in immunology and metabolic related diseases.

Features of CLEA Japan, Inc.’s Non-Clinical Study Services

Comprehensive testing Platform based on laboratory animals

Nippon Crea can provide a comprehensive end-to-end support for non-clinical studies as a long-standing lab animals/ lab material supplier and also can perform in vivo studies and report preparation.

The company has a platform that allows clients to involve from the early stage study designing, such as test item planning, animal preparation, feed adjustment, and cage setup.

Nippon Crea ensures the quality and reliability of its contract studies as they have their own lab facility for in-house testing.

With a proven track record in area of regenerative medicine, the company is widely recognized as a reliable partner in advanced research.

Flexible support for both pharmacology and pharmacokinetics

Nippon Crea supports both pharmacodynamic and pharmacokinetic studies, offering comprehensive assistance from the research stage to practical applications.

In addition to efficacy evaluation in animal models, they provide a full range of ADME assessments— absorption, distribution, metabolism, and excretion.

By handling every step from experimental design to data analysis and GLP-compliant reporting, Nippon Crea provides precise and goal-oriented support that is tailored to each stage of the drug discovery process.

Animal welfare and quality management by international standards

Fully accredited by AAALAC International, Nippon Crea is compliant with global standards for animal welfare and research ethics.

Consistent quality control and traceability throughout breeding and reproduction processes ensure high reproducibility in their non-clinical studies.

They can also provide reliable testing platform with GLP standard for studies for pharmaceuticals and regenerative medicine, which has strict regulatory environment.

Example of a Disease Model Available at CLEA Japan, Inc.

Parkinson’s Disease Model Using 6-OHDA

For Parkinson’s disease—a representative neurodegenerative disorder—Nippon Crea offers a model using 6-hydroxydopamine (6-OHDA).

This model selectively damages dopaminergic neurons in the midbrain, reproducing symptoms such as tremors and motor dysfunctions.

It is applicable to preclinical studies aimed for investigating disease pathology and exploring novel therapeutic approaches, and is also available as a part of the company’s non-clinical contract study services.

Reference: https://www.clea-japan.com/promotion/previous_service/parkinson

Non-Clinical Case Study byCLEA Japan, Inc.

Microbiome Study Support Utilizing Gut Microbiota

Nippon Crea also provides microbiome studies focusing on the correlation between gut microbiota, immune function, and many other symptoms of the disease.

They can support the discovery of disease biomarkers, pharmaceuticals and functional foods.

Nippon Crea offers flexible study designs tailored to specific research needs. Clients can expect thorough protocol consultation, study execution and timely reporting. This can also be utilized at the initial screening stage as a non-GLP study.

Reference: https://www.clea-japan.com/products/service/item_c0050

Corporate Information

Address1-2-7 Higashiyama, Meguro-ku, Tokyo, Japan
Tel03-5704-7011
Websitehttps://www.clea-japan.com/

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