Pharmacology study & consulting service

We support cutting-edge research by receiving requests for pharmacology study from over 1,000 pharmaceutical companies and bio-tech in 30 countries around the world.

Service overview

Pharmacology study

Providing drug efficacy evaluation study using inflammation and fibrosis model mice

Histopathological analysis (paraffin block preparation, staining, and scoring)

  • Providing analysis results of clinical specimens from rodents

Specialized area

Pathological model mice with inflammation and fibrosis as keywords

Well-versed with fibrosis models for each organ (liver, skin, kidney, lung, intestine)

Histopathological analysis

  • Establishing a new immunostaining assay and scoring method using our accumulated knowledge and technique from evaluating MASH/NASH and fibrosis
  • In MASH/NASH/fibrosis models, we can identify balloon-like degeneration in our client produced specimens, which is known to be difficult to evaluate by a third party in Non-clinical pharmacology studies

Non-clinical pharmacology studies

  • High-quality drug efficacy and pharmacology testing based on our research expertise
  • Comprehensive Line-up of various disease models related to fibrosis, inflammation, metabolic disorders, and cancer
  • Strategic research design proposal from our experienced scientists

Benefits for our clients

  • Objective data package
  • Established pharmacological studies

We are a non-clinical CRO with extensive experience in various disease area based in Tokyo.
We own many established disease models including ”fibrosis”.

Our animal facilities are approved by the National Institutes of Health (NIH). We have obtained Animal Welfare Assurance approval and you can receive our contracted services utilizing subsidies from the U.S. Public Health Service (PHS).

Histological imaging

  • High-quality analysis, Proven skills in histology
  • Detailed and comprehensive report by our experts
  • Professional support for data publication/IND applications

Our CRO service process

  • At SMC, we work closely with the client to fully discuss the study design and content so that it can be tailored to the clients needs.
  • A non-disclosure agreement (NDA) is available if necessary.
  • Once a study design has been agreed upon, we prepare a study protocol and discuss the fine details of the study content with the client.
  • At this point, we also prepare a Master Services Agreement (MSA) in order to proceed smoothly with contractual procedures.
  • When all the details of the study protocol have been finalized, we provide the client with a formal quote and work order form.
  • After receiving the signed work order, the first invoice will be issued, and study preparation will begin.
  • The client needs only to make preparations for the shipping of the test substance, and SMC will carry out the rest.
  • During the treatment period, we keep in close contact with the client, providing updates on the general condition and weight changes of the mice every week.
  • At the end of the in-life portion of the study, samples are collected and analysis is performed according to the study protocol.
  • Analysis results can be submitted as interim data before the final report is delivered, and we are able to be flexible with deadline scheduling should there be a specific date by which data is required.
  • After analysis is complete, a study report is compiled and submitted. The second invoice is issued with the report submission.
  • We welcome discussion of the study results between clients and our research team, and are happy to share our interpretation of the results and suggestions going forward.



Our pathology specialists support the construction of experimental analysis systems, data acquisition and explanation of results, and maximize the information from the histology samples of pharmacology studies conducted by clients.


With our expertise in inflammation and fibrosis, we will perform histopathological quantification and scoring for each tissue.

List of evaluation items

  • Fibrosis evaluation

    alpha-SMA immunostaining, ER-TR7 immunostaining, Sirius red staining, Masson trichrome staining, etc.

  • Inflammation evaluation

    F4 / 80 immunostaining, Gr-1 immunostaining, CD4 immunostaining, etc.

  • Fat deposition evaluation

    Oil red staining

  • Cell proliferation / apoptosis evaluation

    Ki67 immunostaining, TUNEL staining, etc.

  • Human tissue evaluation

    HE staining, Sirius red staining, etc.

Utilizing our expertise in fibrosis, we provide a fibrosis analysis method suitable for each disease model tissue.

  • Alpha-SMA immunostaining

    Alpha-SMA immunostaining

    Model: DSS model

  • Sirius red staining

    Sirius red staining

    Model: UUO model

  • Masson trichrome staining

    Masson trichrome staining

    Model: BLM model


Processing & Embedding

  • Embedding of human and animal tissues in paraffin (FFPE blocks) from fixed tissues.

  • Embedding of human and animal tissues in OCT (frozen OCT embedded tissues) from fixed tissues.

Instruction of fresh frozen block preparation for frozen sections.

  • Cutting of sections (4-8 µm thick) from paraffin and O.C.T. embedded blocks.
  • Preparation of serial thin sections.

Routine staining

  • HE, Sirius red, Masson trichrome, PAS, Oil red, etc.

Immunohistochemistry (IHC): Inflammation-related molecules, fibrosis-related molecules etc.

  • Functional Immunohistology(Double/multiple staining).

Imaging analysis

  • Area, length, diameter, stained cell count, percentage positive area, shape etc.
  • Proliferation, Apoptosis, pathological grading etc.

Interpretation of results

  • Discussion of the histological findings in view of pharmacology.

User support

  • We can also set up a place for us to explain our findings and have a discussion with our researchers.


Histopathological parameters are important endpoints in nonclinical as well as clinical studies in NASH and liver fibrosis.

SMC’s outstanding performance in MASH/NASH/liver fibrosis research

  • As a leading CRO in MASH/NASH, SMC has accumulated know-how by assessing over 500 pharmacology studies and 50,000 slides of MASH/NASH and related diseases in mouse, rat and human.
    - judgment of NAS (especially, ballooning), assessment of pathological changes from disease control, discussion of clinical relevance… and more!

    NAS; NAFLD Activity score


  • Assessment the grade of disease (MASH/NASH, fibrosis) in not only nonclinical pharmacology studies but also clinical studies.
  • Development of animal models (including Tg and KO mice) for drug evaluation in the clients’ own laboratory.
  • Achievement of high quality report/data package with objective evaluation.
MASH /肝線維症研究におけるSMCの傑出した性能


NAS (including ballooning, inflammation, steatosis) is an important parameter to evaluate the drug efficacy in MASH/NASH in both human and animal models.
In order to translate nonclinical results into clinical practice, it is essential to discriminate “true”- from “pseudo”-ballooning in disease models.



An accurate scoring can evaluate the efficacy of the test substances on each components (steatosis, lobular inflammation, hepatocyte ballooning) of NAS.


PDF Document



Centered around our proprietary STAM™ model, we offer a lineup of 25 highly-rated SMC quality models. We also provide transportation, material supply, and other services in order meet your needs.

Disease model mice / Biological sample service

On top of supplying pathological model mice, SMC Laboratories can also provide clients with blood, tissue, and other various biological samples. The approximate delivery date for samples from each model mouse varies.

Target organ

  • Whole blood
  • Plasma
  • Serum
  • Brain
  • Eyeball
  • Heart
  • Stomach
  • Lung
  • Liver
  • Kidney
  • Gastrocnemius/
    soleus muscle
  • Skin from the back
  • Thigh muscle
  • Thymus
  • Genitals
  • Small intestine
  • Large intestine
  • Caecum
  • White adipose tissue
  • Brown adipose tissue


From the preparation of our disease models, to the pharmacological analysis and pathological evaluation, we consider everything in regards to the clinical research process.
In other words, we strive to make our research easily translatable to the clinical research phase.
Model preparation: Our models have clear similarities with clinical onset mechanisms Pathology: Our models utilize the same pathological evaluation methods as clinical trials