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Clinical Trial Business

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Multi-Regional Clinical Trials

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.

Contract Flow for studies to be conducted globally

Contract Flow for studies to be conducted globally
Contract Flow for studies to be conducted globally

Quality Management for Global Outsourcing Laboratories

Selection of outsourcing contract global laboratories

Investigation and Evaluation of global partner laboratories

Major Investigation/evaluation items: Financial status/stability, Organization, Competitors, Experience, Facilities/Equipment, Accreditation, Regulatory Compliance, Quality Management System and so forth.

On-Site Facility Audit

Visit to outsourcing contract laboratory candidates and inspecting the lab status such as study operation management procedures and quality assurance system.

Quality Management upon study award and during study operation

Review of Testing Methodology Outline

Reviewing the testing in detail (tests, testing method, reagent, equipment, and report format, and so on)

Periodic Monitoring

Internal/External quality control records, Equipment/Reagent management records, and following up Quality-related actions

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