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Clinical laboratory dedicated to clinical trials(C-lab)

As part of our attempts to further build on our central laboratory services, LSI Medience has put in place a dedicated clinical laboratory for carrying out clinical trials ("C-lab"). This is the first C-lab to be established in Japan and is aimed at conducting a full range of clinical trials.

The laboratory fully meets all of the relevant international standards for clinical trial and operates at similar levels to corresponding facilities in Europe and the U.S. This is in addition to providing for a range of test items required for evaluating the safety and efficacy of new drugs. (We are currently involved in the gradual expansion of test items.)The laboratory has been authorized as having Level 1 certification for HbA1c testing by the U.S. National Glycohemoglobin Standardization Program (NGSP).

A global-standard C-lab that

  • Allows the long-term storage of essential data

    The C-lab has fully implemented measures for the traceability and long-term storage of test data that follows Good Clinical Practice (GCP). All raw data is stored semi-permanently so that tests results can be traced back to original data.

  • Has consistent testing methods

    The drug development process requires testing to be conducted using consistent standards from start to finish. The C-lab responds to clinical trial demands using validated testing methods.

  • Uses a Information system conforming to the requirements for drug development

    The C-Lab Information System (CLABIS) is specially developed for clinical trials to ensure that client’s important data is not lost or subject to accidental changes.
    Data is further protected by the lab’s highly reliable system for clinical trials that provides for various back-up features, such as system validation and an audit trail.

C-lab’s test items

  • Includes testing for biochemistry (49 items), hematology (12 items), and urianalysis (13 items), in addition to a variety of specific clinical trial test items that can be carried out after consultation with the laboratory.
    We are currently involved in the gradual expansion of test items.

“CLABIS” information system

A highly reliable information system that meets the demands of clinical trials while taking into account the U.S. FDA’s Part 11 Rule.

  • System validation : System validation that guarantees quality
  • Access management : Limited to specified users only
  • ID and password management (password changes every 90 days)
  • The system comes equipped with a timed log-out facility to ensure security
  • Control of operating authority : Access is limited to each administrator
  • Data storage and preventing falsification : Difficult to simply erase data once entered
  • Digitization of raw data : Electronic recording : Test results are recorded in real time
  • Audit trail function : Data is fully searchable when reexamining information
  • System management : Limited to system administrator and system manager (provides ability to manage system construction, management, and maintenance)

All of our research and studies are in strict adherence to the laws concerning protection and management of animals in full respect of the standards concerning care and management of test animals, and have been accepted and certified for animal welfare practices.

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