Nonclinical and Clinical Services

Accreditation and Quality Management SystemsCentral Lab Services

The company’s operations are executed with a high sense of accountability based on a thorough audit and certification system, underpinned by the strictest control standards at every stage of the drug development process.

  • Clinical testing is carried out based on a range of strict control standards, based on CAP and ISO15189
  • We provide an independent audit section dedicated to monitoring clinical testing in order to fully meet the high standards required in carrying out clinical laboratory testing

Types of certification

As part of LSI Medience’s drug development services (Bioanalysis Service and Central Lab Service) the company has acquired certification in the global-level ISO9001 standard for quality control systems.

Together with looking to clarify responsibility and jurisdiction in the testing process, we are also involved in standardizing test technology and looking to provide test results that are accurate, trustworthy and based on the strictest standards of quality control.

NGSP

LSI Medience’s dedicated clinical testing laboratory (C-Lab) acquired the international standard of Level 1 Laboratory status for HbA1c testing from the U.S. National Glycohemoglobin Standardization Program (NGSP) in January 2006. The lab is currently the only such facility in Japan to have received this globally-recognized certification.

Measurements involved in HbA1c testing are currently undergoing attempts at standardization within Japan through the efforts of the Japan Diabetes Society (JDS). Recent years have also witnessed increased efforts towards use of globally recognized values in this field by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Despite these efforts, however, NGSP is still recognized as the globally recognized standard in North America and Europe, and all of these figures do correlate with one another.

NGSP accreditation is held by the majority of laboratories involved in clinical testing in North America and Europe, and the acquisition of Level 1 certification by the company’s C-lab means that we can handle requests for clinical testing from both international and domestic clients from within Japan.

  • The Central Lab Service’s overall operations are based on a structure rooted in Good Clinical Practice (GCP), and an study coordinator has been appointed for each protocol, allowing the company to carry out operations in this area with a high sense of accountability.
  • Clinical laboratory testing is carried out based on a range of strict control standards, based on CAP and ISO15189
  • We provide an independent audit section dedicated to monitoring clinical testing in order to fully meet the high standards required in carrying out clinical laboratory testing
GCP Organization (Drug Development Service Division, Medi-Chem Business Segment)

GLP (Good Laboratory Practice)

GLP refers to the Ministerial Ordinance for Standards of non-clinical study on pharmaceutical safety, which is based on regulations stipulated within the Pharmaceutical Affairs Law. At the company’s Drug Analysis Center, Kashima Laboratory, and Kumamoto Laboratory, we ensure confirmation of type-A evaluation to confirm safety in line with the Pharmaceuticals and Medical Devices Agency. Within the field of drug development service the company is able to provide test data that is of the highest possible standard.

We also perform all the safety studies in compliance with the various GLP regulations such as the Industrial Safety and Health Law, Chemical Substances Control Law, Agrochemicals, OECD, etc. at the Kashima Laboratory, Kumamoto Laboratory, and Yokohama Laboratory.

Recent GLP Inspections and Results (Year: Judgment) of Toxicological Science Division

Ministry of Health, Labour and Welfare
Pharmaceuticals Chemical Substances Industrial Safety and
Health Law
2011
Kashima: A
2012
Kashima: pass
2011
Kashima: pass
2012
Kumamoto*1: A
2012
Kumamoto: pass
 
2011
Shimura*2: A
   
Ministry of
Agriculture, Forestry and
Fisheries
Ministry o
f Economy, Trade and
Industry
Ministry of the
Evironment
Pesticides Chemical Substances
Control Law
Chemical Substances
Control Law
2010
Yokohama: approved
2012
Yokohama: pass
2012
Yokohama: pass
2011
Kashima: approved
Kumamoto: approved
   
*1:
including medical devices
*2:
toxicokinetics
Example of GLP Organization (Drug Analysis Center, Drug Development Service Division)

We have also implemented an audit system using a dedicated audit team that looks at every stage of this process, from initial preparation to storage of data, materials, and samples.

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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