LSIM also collaborates with local/global laboratories to realize smooth setup of Multi-Regional Clinical Trials and their operation throughout the study life cycle through close communication.
Major Investigation/evaluation items: Financial status/stability, Organization, Competitors, Experience, Facilities/Equipment, Accreditation, Regulatory Compliance, Quality Management System and so forth.
Visit to outsourcing contract laboratory candidates and inspecting the lab status such as study operation management procedures and quality assurance system.
Reviewing the testing in detail (tests, testing method, reagent, equipment, and report format, and so on)
Internal/External quality control records, Equipment/Reagent management records, and following up Quality-related actions