Using an "open" technology concept, the Cobas 6000 provides for easy-to-use reagents as well as those not provided by the manufacturer, promoting optimization of protocols and allowing SGS to offer additional tests that can be validated as well as to meet GLP requirements, according to the company. All results are entered directly into the Watson LIMS (Laboratory Information Management System) for traceability of analysis and can be grouped by patient even if the results are obtained during long-term kinetics.
"This progress will permit the SGS Poitiers site to provide more analysis of biomarkers in a GLP environment and complies with the latest guidelines of Good Clinical Practice (GCP)," said Alain Renoux, director of SGS Life Science Services, Poitiers. "From a clinical protocol compliance perspective, the Cobas System 6000 ensures traceability of the sample before and after dosing, and allows trial sponsors to limit the volume of biological matrix collected in the patient."
The company also recently completed the qualification of a new Hitachi L-8900 Amino Acid Analyzer at its lab in Clichy, near Paris. This instrument is used to perform the analysis of amino acids in compliance with pharmacopoeial requirements (EP Section 2.2.56 and USP <1052>).