CRO & CONSULTING SERVICE INFO.

CRO & CONSULTING SERVICE INFO.

Non-clinical pharmacology services

  • After we receive the test substance, we will administer the compound to the mice, perform takedown and sample analysis and and generate the study report at our facility.
  • We have extensive experience in evaluating a variety of test substances within the field of inflammation and fibrosis.
  • Based on our accumulated knowledge, we can propose and conduct various pharmalogy studies depending on the study purpose and clients needs.

Histological analysis services

  • Third-party evaluation of pathological specimens of customer-made MASH(f.k.a. NASH,hereinafter referred as MASH/NASH) / fibrosis models can be performed.
  • In addition, it is possible to construct an novel experimental system tailored to the purpose.

FACTS AT A GLANCE

  • Founded in October 2006
  • A privately-held non-clinical CRO based in Tokyo, Japan;
    specialized in research on fibrosis and inflammation
  • Our animal facilities received the approval of Animal Welfare Assurance for foreign institutions from the Office of Laboratory Animal Welfare (OLAW) of the National Institutes of Health (NIH) on November 30, 2015.
    This is an assurance by the OLAW that SMC’s facility meets the standards of United States Public Health Service (PHS) policy and PHS-funded animal activities. PHS funding components include the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA).
  • CRO services
    • Non-clinical pharmacology
      • One of the leading CRO in liver research with Proprietary MASH/NASH-HCC (STAM™) Model
      • In vivo disease models for metabolic disorders, inflammation, fibrosis and tumor
    • Histological imaging services
      • Histological scoring: NAFLD Activity score, fibrosis and inflammation scores etc.

SMC'S CRO SERVICES

  • Non-clinical pharmacology study

    • High-performance pharmacology utilizing the company’s expertise in resealch
    • Lineup of various disease models relating to fibrosis, inflammation, metabolic disorders and cancer
    • Strategic study design proposed by experienced physicians and scientist

  • Histological imaging

    • In-house, high quality analyses; proven skills in histology
    • Elaborate and comprehensive reports by Ph.D. holders
    • Professional support for data publication/IND application

CRO

Our CRO service process

  1. 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.

  2. A non-disclosure agreement (NDA) is available if necessary.

  3. 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.

  4. At this point, we also prepare a Master Services Agreement (MSA) in order to proceed smoothly with contractual procedures.

  5. When all the details of the study protocol have been finalized, we provide the client with a formal quote and work order form.

  6. After receiving the signed work order, the first invoice will be issued, and study preparation will begin.

  7. The client needs only to make preparations for the shipping of the test substance, and SMC will carry out the rest.

  8. 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.

  9. At the end of the in-life portion of the study, samples are collected and analysis is performed according to the study protocol.

  10. 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.

  11. After analysis is complete, a final report is compiled and submitted.

  12. 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.

Portfolio: non-clinical pharmacology models

STAM™ : Premium preclinical platform for MASH/NASH-hcc

  1. Phormacology study

    • For efficacy evaluation of drug candidates/existing drugs
    • Histologycal review with in-depth knowledge of inflammation and fibrosis

  2. Delivery of stam™ mice samples

    • For target(biomarker) discovery and validation
    • Provided as tissue and/or plasma(serum) samples

Conventional disease models

CRO & CONSULTING SERVICE
CONTACT