Non-clinical studies can be divided into three categories: Pharmacodynamics(PD), Safety/Toxicology, and Pharmacokinetics(PK).
In this site, we will guide you through your CRO selection process and help you find the most suitable non-clinical CRO for your needs.
Pharmacodynamics(PD) CROs -- where each CRO is specialized in vastly different therapeutic areas,making it challenging to select the right partner.
Here are theSummarized key points when you are selecting the right partner CRO depending on your needs.
| Pharmacodynamics(PD) Studies |
Toxicology Studies | Pharmacokinetic Studies(PK) | |
|---|---|---|---|
| Your Target Goals | The new drugConfirm the pharmacological action and evaluate its efficacyPharmacodynamics(PD) Studies |
To evaluate the toxicity and side effects of the drug and confirm its safety. |
To evaluate how a new drug moves through the body ( Absorption, Distribution, Metabolism, and Excretion ). |
| Tips for choosing the Right CRO |
|
|
*Same standards as Safety/ Toxicology Studies. |
Our editorial team has curated a list of Non-clinical contract research organizations (CROs).
Each company offers its specialty in Pharmacology(PD), safety/Toxicology, and Pharmacokinetics(PK). We recommend you use our tips below when choosing your partner CRO for your studies.
Provides high-quality pharmacological evaluation studies based on specialized research expertise.
Offers various disease murine models in fibrosis, inflammation, metabolic related, and cancer.
We provide best-in-class efficacy studies: strategically designed, scientifically sound.
| Address | Technoport Kamata Center Bldg., 2-16-1 Minami Kamata, Ota-ku, Tokyo |
|---|---|
| Tel | 03-6715-9101 |
| Website | https://www.smccro-lab.com/jp/ |
Offers high-quality safety, pharmacology(PD), and pharmacokinetic(PK) studies following standard guidelines.
Specializing Core battery safety pharmacology test in Mice and Rats, as well as a wide range of Pharmacological assessments(PD).
| Address | 1-31-8 Takadanobaba, Shinjuku-ku, Tokyo |
|---|---|
| Tel | 0493-54-3239 |
| Website | https://www.dstc.jp/ |
Conducts safety/ Toxicology, Pharmacology(PD), and Pharmacokinetic(PK) study in compliance with standard guidelines.
Some features including diverse Non-clinical testing capabilities using various mice models established under license from universities/ research institutions.
| Address | 1-7-1 Yurakucho, Chiyoda-ku, Tokyo |
|---|---|
| Tel | 0120-34-0412 |
| Website | http://www.ndrcenter.co.jp/ |
The company is contracted to perform a variety of pharmacological studies for cardiovascular, allergic, anti-fatigue, and other medicinal effects. It is a model for pathological conditions.Possesses a unique drug evaluation system using genetically modified animalsThe following are some of the features of this product.
| Address | 582-2 Shio-shinden, Iwata City, Shizuoka Prefecture |
|---|---|
| Tel | 0538-58-1266 |
| Website | https://www.anpyo.co.jp/ |
The company offers a wide range of services from various safety studies, pharmacology studies, and pharmacokinetic studies for regulatory approval applications, including JSTP and JCVP certified pathologists and JSOT certified toxicologists.Strengths of having experts on staffPharmacodynamics(PD) Studies
| Address | 36-1 Shimizu-cho, Itabashi-ku, Tokyo |
|---|---|
| Tel | 03-5943-9270 |
| Website | https://www.mediford.com/ |
Drug discovery projects, from consultation on drug discovery strategies to the execution of individual trialsSupport mainly for lead compound optimization stageWe are a company that has been engaged in the development of new products and services. We have a team of highly experienced engineers who have been cultivated through many contracting projects.
| Address | 36-7 Oyama-cho, Shibuya-ku, Tokyo |
|---|---|
| Tel | 03-5453-8101 |
| Website | https://www.bozo.co.jp/ |
CMIC Holdings proposes services that match your needs, as a contract research facility that is GLP compliant and fully AAALAC certified,Can support various evaluation studies and new drug development plans through to applicationThis is a strength of the company.
| Address | 1-1-1 Shibaura, Minato-ku, Tokyo, Japan |
|---|---|
| Tel | 03-6779-8000 |
| Website | https://www.cmicgroup.com/ |
The company conducts non-clinical studies necessary for the development of pharmaceuticals, medical devices, regenerative medicine products, and chemical substances in accordance with the latest regulations.We also conduct specific efficacy studies in the CNS and ophthalmology areas.This is a strength of the company.
| Address | 2148-188 Nishi-Minowa, Ina City, Nagano Prefecture, Japan |
|---|---|
| Tel | 0265-72-6616 |
| Website | https://www.ina-research.co.jp/ |
We provide high quality safety, efficacy, pharmacology, and pharmacokinetic studies based on various guidelines.Support for numerous studies ranging from Phase I clinical trials to post-marketing surveillanceThe strength of the company is its pursuit of higher quality and safety.
| Address | 2438 Miyanoura-cho, Kagoshima City, Kagoshima Prefecture, Japan |
|---|---|
| Tel | 099-294-2600 |
| Website | https://www.snbl.co.jp/ |
We are a company that handles radiopharmaceuticals, other pharmaceuticals, and regenerative medicine products. We conduct a wide variety of quality tests, and we have established quality control standards for our products.Features radiopharmaceuticals that have passed strict criteriaPharmacodynamics(PD) Studies
| Address | 3-4-10 Shinsuna, Koto-ku, Tokyo, Japan |
|---|---|
| Tel | 03-5634-7006 |
| Website | https://www.nmp.co.jp/ |
The company conducts studies in various disease areas with a focus on pharmacodynamic studies.We can also handle evaluation system start-up tests for Procoats without any experience in implementation.Pharmacodynamics(PD) Studies
| Address | 2-4-9 Bingo-machi, Chuo-ku, Osaka-shi, Osaka, Japan |
|---|---|
| Tel | 06-6202-6338 |
| Website | https://www.nissei-bilis.com/ |
The company's strengths lie in its trust and track record backed by 40 years of history and the technologies accumulated at its GLP facilities. The company is characterized by its wide range of services, from small animal studies to non-clinical studies using large animals.
| Address | Yurakucho Denki Building South Tower 4F, 1-7-1 Yurakucho, Chiyoda-ku, Tokyo |
|---|---|
| Tel | 03-6551-2601 |
| Website | https://transgenic-group.co.jp/ |
High qualityStrengths of using PXB mice, a human hepatocyte chimera mouseThe company's strength lies in non-clinical studies utilizing PXB mice (mice in which more than 70% of the liver has been replaced by human hepatocytes).
| Address | 3-4-1 Kagamiyama, Higashihiroshima City, Hiroshima Prefecture, Japan |
|---|---|
| Tel | 082-431-0016 |
| Website | https://phoenixbio.co.jp/ |
A company that develops many disease models mainly by contracting pharmacological studies, and as a CRO, conducts mainly safety studies and contract pharmacological studies using miniature pigs.
| Address | 6-104 Majima, Fukuju-cho, Hashima-shi, Gifu, Japan |
|---|---|
| Tel | 058-392-6222 |
| Website | https://www.nbr.co.jp/ |
The Compound Safety Laboratory has over 50 years of experience in non-clinical testing since its establishment and is a GLP-compliant facility for all pharmaceuticals, medical devices, and regenerative medicine.
| Address | 363-24 Manae, Kiyota-ku, Sapporo, Hokkaido |
|---|---|
| Tel | 011-885-5031 |
| Website | https://www.ka-anken.co.jp/ |
The company specializes in pharmacokinetic studies and synthesis contract services, including in vivo and in vitro studies, drug discovery and development studies, and synthesis contract services.
| Address | 4-10-9 Takaido Higashi, Suginami-ku, Tokyo |
|---|---|
| Tel | 03-3333-2711 |
| Website | https://www.nemotoscience.co.jp/ |
A company that provides research and development support in various fields including biotechnology-related fields. As an agency, we are a company that is contracted to conduct "pharmacodynamic studies", "toxicity studies", and "pharmacokinetic studies" (in vitro/vivo).
| Address | 17 Nishimizubo-cho, Ichijyoji, Sakyo-ku, Kyoto-shi, Kyoto, Japan |
|---|---|
| Tel | 075-721-8111 |
| Website | https://www.wakenyaku.co.jp/ |
The company provides a wide range of testing services, including blood and urine testing, toxicity testing, and safety pharmacology testing. As a distributor, the company provides total support for genome editing mouse creation and breeding using CRISPR/Cas9, and phenotypic analysis.
| Address | 3-12-6 Suehiro, Chuo-ku, Chiba-shi, Chiba, Japan |
|---|---|
| Tel | 043-265-4141 |
| Website | https://www.yakukensha.co.jp/ |
We are a company that also handles non-clinical (in vivo and in vitro) functional and safety evaluations, identification of involved ingredients, and qualitative and quantitative methods. As a distributor, we partner with facilities specializing in non-clinical studies to conduct more challenging studies.
| Address | 1-8 Tsukudo-cho, Shinjuku-ku, Tokyo |
|---|---|
| Tel | No phone number was listed on the official website. |
| Website | https://www.ep-mediate.co.jp/ |
We are a company engaged in contract research business focusing on non-clinical pharmacokinetic studies using radiolabeled compounds. As an agency, our strength is total solutions combining safety and pharmacokinetic studies.
| Address | Urbannet Nihonbashi 2-chome Building, 2-1-3 Nihonbashi, Chuo-ku, Tokyo, Japan |
|---|---|
| Tel | 03-3272-0671 |
| Website | https://www.sekisuimedical.jp/ |
We are a company engaged in contract research business with a focus on non-clinical pharmacokinetic studies using radiolabeled compounds. As an agency, we conduct licensed studies on genetically engineered mice that have been established and analyzed at universities and research institutes.
| Address | 1067-6 Otsu Otsu, Kochi City, Kochi Prefecture |
|---|---|
| Tel | 088-866-5000 |
| Website | https://www.shikokurika.co.jp/ |
We are the exclusive Japanese agent for contract clinical safety testing. In cooperation with BIOTOXTECH in Korea, we handle a variety of tests in each field, including not only cosmetics, but also food, chemicals, agrochemicals, and pharmaceuticals.
| Address | 1-7-11 Doshomachi, Chuo-ku, Osaka-shi, Osaka |
|---|---|
| Tel | 06-6231-3456 |
| Website | https://www.cosfa.co.jp/ |
We provide high-quality pharmacodynamic and pharmacokinetic studies based on various guidelines. We also work with partner companies to support regulatory submissions for new biomarkers that are essential for drug development.
| Address | Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo |
|---|---|
| Tel | 03-6279-0900 |
| Website | https://www.srl-group.co.jp/ |
We have extensive experience in the measurement of drug concentrations in biological samples in non-clinical and clinical studies, and we perform various concentration measurements in drug development under the GLP and reliability standards system.
| Address | Sumitomo Fudosan Hongo Building 9F, 3-22-5 Hongo, Bunkyo-ku, Tokyo |
|---|---|
| Tel | 03-5689-1211 (Tokyo Head Office) |
| Website | https://www.scas.co.jp/ |
The company works with laboratory animal manufacturers to provide contract animal care and management before, during, and after animal testing, as well as to supply and support testing of the Microminipig®, the world's smallest class of domestic micro pigs.
| Address | Collaboration Building, Aobayama Office, Research Center for Accelerator and Radioisotope Science (RARiS), Tohoku University, 6-3 Aoba, Aramaki Aza, Aoba-ku, Sendai, Miyagi, Japan |
|---|---|
| Tel | 050-3716-5633 |
| Website | https://www.clino.org/ |
As one of the few veterinary CROs in Japan, we are one of the few companies that conducts many contract studies. We conduct a variety of tests to contribute to the production and processing process of food products and to the improvement of food safety.
| Address | 561-21 Araguchi-cho, Maebashi, Gunma prefecture, Japan |
|---|---|
| Tel | 027-230-3411 |
| Website | https://www.shokukanken.com/ |
As a CRO, we have successfully completed INDs in the U.S. and Taiwan and support the development of synthetic and biopharmaceuticals from discovery, submission, and production to clinical trials. The company provides biological testing services.
| Address | Room704, Nihonbashi Life Science Building 2, 3-11-5 Nihonbashi-Honcho, Chuo-ku, Tokyo |
|---|---|
| Tel | 03-6712-7668 |
| Website | https://www.lmed.co.jp/ |
We are a company that is contracted to perform safety testing of pharmaceuticals, medical devices, health foods, and other products. We are capable of conducting tests recommended by international standards such as ISO10993, FDA, ASTM, OECD, etc. as well as the guidelines of the Ministry of Health, Labor and Welfare.
| Address | 729-5 Ochiai, Hadano City, Kanagawa Prefecture, Japan |
|---|---|
| Tel | 0463-82-4751 |
| Website | https://www.fdsc.or.jp/ |
We are a drug discovery support company specializing in non-clinical studies mainly using non-human primates (NHPs). The company's strength lies in its ability to effectively conduct pharmacological studies in various areas where new drugs are desired, such as cerebral infarction, central nervous system diseases, and intractable diseases.
| Address | 1-3-7 ShinMiyakoda, Hamana-ku, Hamamatsu City, Shizuoka, Japan |
|---|---|
| Tel | 053-543-4543 |
| Website | https://www.hpharma.jp/ |
Takara Bio, with its extensive experience in non-clinical testing, has the advantage of GLP safety testing being conducted at facilities that have been approved for GLP compliance for regenerative medicine products, and total support in conjunction with regenerative medicine product manufacturing.
| Address | 7-4-38 Noji-Higashi, Kusatsu City, Shiga Prefecture, Japan |
|---|---|
| Tel | 077-565-6920 |
| Website | https://catalog.takara-bio.co.jp/ |
We provide high-quality, guideline-based safety, efficacy, pharmacology, and pharmacokinetic studies. We also offer a variety of analytical services and in vivo studies to support non-clinical safety, efficacy, and pharmacology studies.
| Address | 3-1-2 Dosho-machi, Chuo-ku, Osaka, Japan |
|---|---|
| Tel | 06-6203-3741 |
| Website | https://www.fujifilm.com/ffwk/ja |
Explicyte is a preclinical and translational research CRO specializing in cancer immunotherapy research and development. We support drug efficacy/pharmacological evaluation and biomarker discovery through immune-related assays, animal model studies, and human sample analysis. We support efficacy and safety validation of cancer immunotherapy through our consistent system from in vitro to in vivo studies.
| Address | 229 Cours de l'Argonne, 33000 Bordeaux, France |
|---|---|
| Tel | +33 (0)5 64 31 11 70 |
| Website | https://explicyte.com/ |
We provide high-quality drug efficacy evaluation studies, mechanism-of-action elucidation, and target exploration studies based on our proprietary PCLS technology. Our strength lies in our ability to reproduce pathological conditions with high precision that preserves the structure of living human tissues. We also support the evaluation of drug efficacy in non-clinical studies in fibrosis diseases of the liver, kidney, and lungs, and mechanism analysis using genetic analysis and other methods to obtain data with high clinical predictive value.
| Address | Unit 26-27, The Pantry Bakers Yard, Christon Road, Newcastle Upon Tyne, NE3 1XD, UK |
|---|---|
| Tel | Not open to the public (please use the contact form on the official website) |
| Website | https://www.fibrofind.com |
Specializing in metabolic and fibrosis areas such as obesity, diabetes, and MASH, we provide high-quality pharmacopharmacological studies and comprehensive analytical services for elucidating mechanisms of action (MoA). In addition to our proprietary models with high clinical predictive power, we also have strengths in AI pathology analysis and whole brain 3D imaging technology, and can provide strong backup for our clients' drug discovery research by handling advanced drug efficacy evaluation and mechanism identification in non-clinical settings.
| Address | Hørsholm Kongevej 11B, 2970 Hørsholm, Denmark |
|---|---|
| Tel | +45 3152 2650 |
| Website | https://www.gubra.dk/ |
We provide high-precision gene editing using proprietary technologies such as Cas-CLOVER, as well as drug efficacy/pharmacology and toxicity studies using immunodeficient rats, SRG Rats. We are strong in acquiring highly predictive clinical data due to our human-like metabolic functions and abundant sample volume, and we can flexibly respond to complex non-clinical studies in the field of oncology and the creation of custom models to meet our clients' needs.
| Address | 2277 Thunderstick Drive, Suite 500, Lexington, KY 40505, USA |
|---|---|
| Tel | +1 859-414-0648 |
| Website | https://www.herabiolabs.com |
We provide drug pharmacology studies utilizing our own high-quality induction kits, as well as ex vivo T cell function analysis and detailed histopathological evaluation. We are particularly strong in inflammation and autoimmune disease models such as multiple sclerosis (EAE) and rheumatoid arthritis (CIA), and can flexibly respond to diverse research needs in the non-clinical stage, from validation of drug targets to clarification of mechanisms of action (MoA).
| Address | 439 South Union Street, Lawrence, MA 01843, USA |
|---|---|
| Tel | +1 617 475 5114 |
| Website | https://hookelabs.com |
We provide high-quality pharmacology and pharmacokinetics (PK) studies based on advanced image analysis technology, and are strong in non-invasive evaluation using OCT and micro-CT, enabling detailed quantitative analysis in the skin and bone areas. We also provide flexible customization of test systems according to research phases while taking animal welfare into consideration, and strongly support the acquisition of highly reliable data in drug discovery research.
| Address | 64 impasse de la Viguerie, ZA La Masquère, F-31750 Escalquens / Toulouse - FRANCE |
|---|---|
| Tel | +33 (0)9 72 60 18 16 |
| Website | https://imavita.com/ |
We are a global integrated CRDMO with research sites in India and France. We provide a full range of services from target identification in the early stages of drug discovery, to non-clinical pharmacology, DMPK and toxicology studies, to scale-up manufacturing of active pharmaceutical ingredients (APIs).
| Address | India (Bengaluru, Noida, Greater Noida), France (Saint-Julien-en-Genevois) |
|---|---|
| Tel | +91 120 436 1000 (Representative of Head Office in India) |
| Website | https://www.jubilantbiosys.com/ |
We are a global full-service contract research organization (CRO), providing integrated toxicology, DMPK, and safety evaluations required for IND and CTA approvals. Our services range from small molecules to modalities such as cell and gene therapy (CAR-T).
| Address | Harumi Triton Square Office Tower Y 8F, 1-8-11 Harumi, Chuo-ku, Tokyo (Labcorp Development Japan K.K.) |
|---|---|
| Tel | 03-6837-9500 |
| Website | https://www.labcorp.com/jp/biopharma |
A not-for-profit, non-clinical CRO based in New Mexico with strengths in respiratory diseases, infectious diseases, and gene therapy, the company has been in business for nearly 80 years, since 1947, and owns a large GLP-compliant facility, ABSL-3, and other equipment.
| Address | 2425 Ridgecrest Drive SE, Albuquerque, NM 87108, United States |
|---|---|
| Tel | 505-348-9400 |
| Website | https://www.lovelacebiomedical.org/ |
We are a contract research organization (CRO) for non-clinical studies with deep expertise in the fields of neurological diseases, pain, and inflammation. We provide flexible study programs from the early stages of drug discovery to the transition to clinical trials, and support the acquisition of highly accurate data.
| Address | 45 Prospect Street, Cambridge, MA 02139 (US location) 4 Eli Horovitz St. Rehovot, Israel (Israel location) |
|---|---|
| Tel | +1 (617) 764-6555 (U.S. location) |
| Website | https://www.mdbiosciences.com/ |
Non-clinical CRO with screening platforms theraTRACE and opioidTRACE, with over 150 validated animal models ranging from metabolic and neurological diseases to pain and oncology.
| Address | 860 Springdale Drive Suite 500 Exton, PA 19341 |
|---|---|
| Tel | (610) 280-0633 |
| Website | https://www.meliordiscovery.com/ |
We highlighted some of the key elements on how to approach Non-clinical studies.
These are some approaches that are undergone by many Pharmaceutical companies and many other Medical communities.
For some indications, there are well established animal models available and others commercially available drugs are on the market. However, for the rest of diseases, there’s a huge need for appropriate animal models in research that has high human translatability.
Many major pharmaceutical companies and start-up biotech companies has Pipeline in Oncology field. Here we will explore a few case studies of how each drug was developed in Oncology indication. We will also share which animal model was used in each of their Non-clinical studies.
Autoimmune diseases happen when your immune system damages your body instead of protecting it. Since it affect large percentage of population, there is a growing demand for a new therapy.
Here, we present some examples of how some pharmaceutical companies have approached in Autoimmune diseases and their case studies in Non-clinical studies.
Fibrosis, the excessive accumulation of fibrous connective tissue, can lead to permanent scarring, organ malfunction and, ultimately, death . It affects major organs such as the liver, lungs, and kidneys. It impairs organ function and significantly reduces patients’ quality of life. There are no effective treatments currently available. We highlighted some examples of Drug Development efforts for Fibrosis indication.
Neurodegenerative diseases are conditions in which the brain and nervous systems gradually lose its function—Alzheimer’s and Parkinson’s disease being the most well-known diseases. There have been many strategic approaches for various innovative therapies through continuous trials and studies in this field. Here, we will introduce some of the examples of how actual Drug Development has progressed over time.
Metabolic disorders, such as diabetes, high cholesterol, and obesity, are often stemmed from a complex mix of lifestyle factors and genetics.
Non-clinical studies play a crucial role in the development of new therapies. We will showcase examples of how new drugs are developed for metabolic disorder treatment.
Atopic dermatitis is a chronic skin condition characterized by persistent inflammation and intense itching. It affect patients’ quality of life (QOL) significantly. Treatments have been developed through antibody therapies and small-molecule compounds. Here, we highlight some examples of drug development for atopic dermatitis treatment, and show you how innovative therapies are brought to life.
Depending on your target goal, there are many different approaches to Non-clinical studies. Your choice of animal models can differ depending on many factors;target indication, MOA of your candidate drugs, and so on. Non- Clinical studies are less known to most people, when compared with clinical trials,
We summarized the essential key points you should know before inquiring a Non-clinical study.
In Japan, pharmaceutical testing is mainly classified into three types: Pharmacological efficacy studies, Safety studies, and Pharmacokinetic(PK) studies. These studies are essential for drug development and regulatory approval.
Read more about study typesChoosing the right animal models for a non-clinical study plays a crucial role in drug development. Different animals are susceptible to different diseases, and factors such as ease of handling and management also influence the selection of the appropriate species.
Read more about animal modelsCandidate compounds are compounds identified early in the drug development process and selected for evaluation of their potential efficacy and effectiveness as new drugs.
About the Compound LibraryPathological models are animal models developed to reproduce a specific disease or condition. When evaluating the efficacy of a new drug in non-clinical studies, the use of pathological models makes it possible to conduct experiments using animals with symptoms and disease states similar to those of actual patients.
What is a pathological model?Generally, it takes more than 10 years from the discovery of a drug candidate to its approval as a new drug. Clinical trials are a key step in the rigorous process of new drug development, and are a key step in the application for approval.
New Drug Development Process