DATA INTEGRITY AND COMPLIANCE THROUGH PROACTIVE, COLLABORATIVE APPROACH: Acetaminophen Assay Change Management with Expanded Laboratory Management Solutions (ELMS)

As the percentage of clinical trial testing performed by external labs gradually increased, Covance anticipated sponsors' needs for more rigorous quality management and performance monitoring and, to this end, launched new Expanded Laboratory Management Solutions (ELMS) in September 2013. On one occasion, ELMS detected a change in the reporting range used by an external laboratory performing acetaminophen testing for a series of studies. Covance Central Laboratory Services (CLS) worked closely with the external lab to manage potential quality implications.

Copy and paste this URL:

https://biopharma.labcorp.com/latest-thinking/explore-library/detail.html/covance/assetLibrary/casestudies/ELMS-Acetassay-CSCLS008.pdf