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Clinical Trial Business

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Central Lab Services

All samples collected at sites across the nation for clinical trials are delivered to our Central Laboratory located in Tokyo for centralized analysis. This will eliminate differences in comparison among sites and enable easy test results analysis due to unified test methodologies and reference intervals.
LSIM also collaborates with local/global laboratories to realize smooth setup of Multi-Regional Clinical Trials and provide effective and intimate operation throughout the study life cycle.

Here, details of Multi-Regional Clinical Trials support

Central Lab Services Flow

Central Lab Services Flow
Central Lab Services Flow

Project Management

Study Coordinator ("SC") is designated per contracted study. SCs are responsible for the whole process of the studies from set-up through the end of the studies. SCs direct the entire projects to meet the requirements of the sponsors and makes arrangements before clinical study initiation such as Study Specific Procedures preparation, system set-up, and testing kits building. Also, during clinical study, SCs instruct the study operation such as sample pick-up and delivery of lab test results report, and manages various study information.

Testing Kits Assembly

LSIM design and assemble "Testing Kits Set" packages which contain sample collection containers, sample collection manual, requisition form and so on according to Protocol, and deliver the packages to investigational sites.

Study Set-up

Our experienced staff members pay a visit to each investigational site before clinical study initiation to perform the set-up activities: explanation about the testing kits set, meeting on sample collection procedures, checking the delivery address of the lab test results report, and so on.

Sample Pick-up

LSIM has a network to pick-up samples from investigational sites across the nation, and deliver the samples to our Central Laboratory under appropriate temperature control and in optimal condition.

Testing

LSIM undertakes centralized analyses of samples at our Central Laboratory. The Central Laboratory has maintained ISO15189 as global standard for clinical laboratory, and College of American Pathologists (CAP) accreditation.

Testing Field

  • Biochemistry test, Drug Toxicity test, Endocrinology test, Tumor-related test, Virology test, Immunoserological test, Cellular immunity test, Gene-related test, Chromosomal test, Hematology test, Microbiological test, General clinical test, Pathological test.
  • Various microbiological test/study necessary for antibacterial drug development
  • With more than 2,000 tests LSIM laboratory covers wide range of tests from general safety tests to specialized tests. Furthermore, LSIM responds to clients' need by constantly developing and validating new tests.
  • LSIM perform various microbiological test/study necessary fordrug development.
    • Bacteriology:
      Aerobic and anaerobic pathogenic bacteria, Enterobacterales, MRSA, Clostridioides difficile, Mycobacterium and etc. from patient specimens is detected by following assay.
      • Gram stain
      • Isolation and identification from specimen culture
      • Susceptibility testing
      • Nucleic acid amplification test
    • Mycology:
      Pathogenic yeast and mold, Candida, Cryptococcus, Aspergillus, Trichophyton and etc. from patient specimens is detected by following assay.
      • KOH stain
      • Isolation and identification from specimen culture
      • Susceptibility testing
      • Nucleic acid amplification test
    Microbiological Services in Antimicrobial Development

  • LSIM is offering measurement services for neutralization antibody titer against viruses in specimen such as human serum.
    LSIM is capable to perform customization of assay method, validation, measurement on diagnostic samples as well as clinical trial samples, and to support vaccine development, clinical trial, post-marketing surveillance, epidemiological survey and so on. LSIM performs the assay in accordance with ISO15189 and provides a final report and electronic data to meet the expectations by sponsor.
    Measurement Services for Neutralization Antibody Titer

Lab Test Results Report and Data Service

  • The lab test results reports are sent to the investigational sites and sponsors.
    The reporting is available in paper by mail, via fax, or in PDF format.
  • LSIM provides the following services as data service
    • Monitor support system (prompt alert information, notification by email, and so on)
    • Data management support system (provision of electronic data)

Sample Management

Long-term storage of remaining samples: LSIM ensures that remaining samples are securely stored at -20 centigrade freezers.
Furthermore, samples can be delivered to other designated laboratories upon clients' request or anonymized.

Documents Archiving

LSIM archives the documents such as study operation materials and records generated during the study period for a long period of time.

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