Nonclinical Efficacy Testing » Non-Clinical CROs and Agencies » Safety Research Institute for Chemical Compounds Co., Ltd.

Safety Research Institute for Chemical Compounds Co., Ltd.

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Table of Contents

Established in 1970, Compound Safety Research Institute, Inc. (CSRI) has provided GLP-compliant non-clinical studies.

This page will walk you through the institute’s key features, representative disease models, and examples of their non-clinical studies.

We hope it serves as a useful reference when selecting a CRO for your non-clinical studies.

Non-Clinical Studies at Safety Research Institute for Chemical Compounds Co., Ltd.

Extensive Experience and Proven Track Record

Since 1970, CSRI has built a solid record in non-clinical testing for over 50 years. They provides high-quality safety, efficacy, pharmacology, and pharmacokinetic studies.

They have teams who are knowledgeable in both GLP and GCP regulations, which ensures each client with highly reliable data.

Comprehensive One-Stop Support system

CSRI offers seamless support from non-clinical through clinical stages, including GLP study design, execution, and submission assistance.

By handling all procedures in-house, it improves drug development efficiency and reduces overall cost through an integrated system.

Broad Scope of Services

CSRI conducts safety studies for pharmaceuticals, medical devices, regenerative medicine products, agrochemicals, and various chemical substances. their facilities are fully compliant with all GLP standards and are equipped to perform biological safety studies from Class I to Class IV.

Partnered CROs with CSRI

Hokudo Corporation

Hokudo specializes in contract non-clinical studies and antibody production.

Leveraging extensive experience and technical expertise, the company excels in pig-based pharmacological and toxicological testing and has developed rare animal models such as spinal cord injury and COPD models.

Fukushima Medical Device Development Support Center

This center conducts implantation and other non-clinical studies using large animals (swine).

They provide GLP/ non-GLP studies, and also offers training programs in medical procedures including cardiovascular and gastrointestinal systems.

Case Studies available at Safety Research Institute for Chemical Compounds Co., Ltd.

Reproductive and Developmental Toxicity Studies

Over the past five years, CSRI has completed approximately 50 GLP-compliant reproductive and developmental toxicity studies, supported by a team of Reproductive and Developmental Toxicologist.

They have also provided many studies for fertility and early embryonic development, prenatal and postnatal development, and maternal function, as well as testing compliant to OECD TG414, TG421, and TG422 guidelines.

Reference: CSRI Official Website https://www.ka-anken.co.jp/column/post_11.html

Non-Clinical Studies Using Swine

Compared to dogs or rabbits, swine shares closer anatomical and physiological characteristics with humans, such as body size, tracheal structure, and vascular length.

CSRI offers clinically relevant biological safety studies—including device implantation—with GLP standards, led by veterinarians and teams with extensive clinical experience.

Reference: CSRI Official Website https://www.ka-anken.co.jp/column/post_2.html

Company Information

With over 50 years of experience in non-clinical testing, CSRI operates as a GLP-compliant testing facility for both pharmaceuticals and agrochemicals.

Address 363-24 Manae, Kiyota-ku, Sapporo, Hokkaido
Tel 011-885-5031
Website https://www.ka-anken.co.jp/

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