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.
A Project Manager (“PM”) is assigned per contracted study. PMs are responsible for managing a whole process from preparation to completion of the study. At the study preparation stage, PM fixes a Statement of Work and determines the contents of kit composition and the system setup. When studies proceed, PMs focus on smooth operation towards the end of study through management of sample logistics, laboratory reporting, and prompt response to various requests from sponsors.
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.
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.
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.
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.
LSIM archives the documents such as study operation materials and records generated during the study period for a long period of time.