A site where you can find recommended contractors for non-clinical testing｜effical " 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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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.

3 Specialized Pre-clinical CROs for Advanced Drug Discovery

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/

Leading CROs:
From New Drug Discovery to Redevelopment

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.

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 approachallows 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.

Consult study design and disease model development
with SMC Laboratories, Inc.

Consult SMC Laboratories
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Safety Studies
Comprehensive Safety Evaluation for FIH Applications

Labcorp Holdings Inc.
(Labcorp Drug Development)

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.

Consult Labcorp Holdings Inc.
Discuss GLP/ICH-compliant study design for your FIH submission.

To labcorp.
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Pharmacokinetic (PK/PD) Studies
High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation

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 aseamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.
The company offersan integrated evaluation analysiscovering 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.

Consult Phoenix Bio for PK/PD analysis with a clinical focus

Phoenix Bio.
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