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.
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.
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.
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.
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.