Use of protocol-synchronous LIMS structures to expand the role of the centralized clinical trial laboratory in pharmaceutical research

Clinical trials involving human subjects are a major step in the long process toward approval of new therapeutic agents for the FDA or equivalent agencies in other countries. Increasingly, pharmaceutical and biotechnology firms rely on large central laboratories capable of providing analytical and data services designed exclusively to meet the exacting requirements of Phase I through Phase IV clinical trials. Using a variety of sophisticated, fully integrated information technologies, a state-of-the-art central laboratory can provide pharmaceutical clients with an expanded array of patient and data management services. The advantages afforded by use of advanced information technologies from the central laboratory include improved patient management, more effective day-to-day management of the study, and the assurance that an audited and edited database is always available — from study inception to database lock. This chapter will discuss the unique services provided by the centralized clinical trial laboratory and the approach used by one of the larger central laboratories in the USA to meet the needs of its pharmaceutical clients. A functional analysis is presented which compares the implementation of a protocol-synchronous LIMS with traditional sample-oriented systems in meeting the needs of the clinical trial client.