PRECISION-DRIVEN REVIEWS DELIVER FDA-COMPLIANT RESULTS AND SAVE TIME: Change Management for Proprietary Assays with Expanded Laboratory Management Solutions (ELMS)

Occasionally, Covance Central Laboratory Services (CLS) calls upon external labs for help with either rarely performed or proprietary assays. In this case, we had to send a proprietary hepatitis marker assay, used in screening trial patients, to the only referral lab in the US that can currently handle it. The lab informed us that there was a change in methodology. In order to ensure data consistency in ongoing client trials, Covance Expanded Laboratory Management Solutions (ELMS) requested validation and correlation data from the external lab.

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