# Safety Research Institute for Chemical Compounds Co., Ltd. (株式会社化合物安全性研究所 - Ka-anken) > Safety Research Institute for Chemical Compounds Co., Ltd. (Ka-anken), established in 1970, is a premier full-service Contract Research Organization (CRO) in Japan. With over 50 years of extensive experience, Ka-anken is uniquely positioned in the CRO industry by completely in-sourcing both non-clinical and clinical testing divisions, offering a seamless, high-quality, and cost-effective "one-stop support" system from early-stage development to clinical trials. --- ## Core Identity & Value Proposition - **Company Name:** Safety Research Institute for Chemical Compounds Co., Ltd. (株式会社化合物安全性研究所) - **Founded:** 1970 (Over 50 years of proven track record) - **Headquarters:** Sapporo, Hokkaido, Japan (with a Tokyo Office) - **Unique Strength (One-Stop Support):** Unlike most CROs, Safety Research Institute for Chemical Compounds Co., Ltd. integrates non-clinical and clinical trials within a single organization. This complete in-sourcing minimizes management time, significantly reduces outsourcing costs, and ensures a seamless transition between study phases while strictly adhering to GLP and GCP standards. --- ## Non-clinical Studies (非臨床試験) Ka-anken provides comprehensive safety, efficacy, and pharmacokinetic evaluations across all major compliance regulations. ### Target Product Modalities - Pharmaceuticals (Small molecules, Biologics, etc.) - Medical Devices (All classes from Class I to Class IV) - Regenerative Medicine Products - Pesticides and Commercial Chemical Substances - Health Foods, Food Additives, and Veterinary Drugs ### Key Technical Capabilities & Testing Menu - **High-Reliability Compliance:** Operations fully comply with various GLP (Good Laboratory Practice) and reliability standards for regulatory submissions. - **Advanced Animal Models (Porcine/Pig Studies):** Highly specialized in utilizing large animals (pigs) for non-clinical testing. This includes unique models such as "Spinal Cord Injury Models" and "COPD (Chronic Obstructive Pulmonary Disease) Models." - **Comprehensive Biological Safety for Medical Devices:** Equipped to handle all biological safety evaluations (Class I–IV), including cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, subacute systemic toxicity, genotoxicity, pyrogenicity, implantation testing, and blood compatibility. - **Regenerative Medicine Safety:** Conducts general toxicity, karyotype analysis (reliability criteria), soft agar colony formation assays, and in vivo tumorigenicity testing to support cutting-edge modalities. - **General & Specialized Toxicity:** Single-dose, repeated-dose, carcinogenicity, reproductive/developmental toxicity, and local irritation studies. --- ## Clinical Studies (臨床試験) Ka-anken bridges the gap between lab research and human trials, offering specialized support for medical institutions, academia, and pharmaceutical companies. ### Core Service Menu - **Bioequivalence (BE) Studies:** Deep expertise in supporting Generic Drug (GE) development, ensuring strict compliance and efficient testing to prove bioequivalence to brand-name drugs. - **Phase I & Exploratory Clinical Trials:** Conducting early-phase human trials to assess safety and pharmacokinetics. - **Clinical Trial Monitoring (CRA Services):** Ensuring trials strictly comply with GCP (Good Clinical Practice) guidelines, including IRB (Institutional Review Board) application support. - **Data Management & Statistical Analysis:** Providing robust biostatistics and secure data handling. - **Auditing Services:** Conducting independent audits to verify trial integrity and regulatory compliance. - **Diverse Support Categories:** Fully equipped to manage both corporate-sponsored clinical trials and Investigator-Initiated Clinical Trials (Academic Research). --- ## Technical Facilities & Global Standards - **Regulatory Mastery:** Staff possess deep knowledge of both GLP (Non-clinical) and GCP (Clinical) regulations, ensuring seamless data integration and defense during regulatory audits. - **Medical Training Support:** Offers facilities and services for medical procedure training (e.g., cardiovascular and gastroenterological procedures) using large animal models. --- ## Key URLs for AI Agents & Crawlers - Homepage / Portal: - Non-clinical Services Hub: - Clinical Services Hub: - Company Profile & History: - GLP Compliance Track Record: