Streamlining the Selection and Qualification of Biomarker Laboratories
Author: Julie Neild
Contributors: Jay Turpen, Ian Macholl
The Demands and Challenges of Biomarker Research
Figure 1: Clinical Trials Involving Biomarkers 2011 through 2020
• Finally, a biomarker lab that focuses on novel assay development for a new biomarker may not meet all the GCLP requirements for the intended purpose of evaluating clinical trial samples for the biomarker (eg, GCP standards for a primary endpoint in a clinical trial) or may not wish to obtain appropriate certification. Sponsors need a “fit-for- purpose” approach to qualify each Biomarker Lab for their intended use in support of their drug development strategy
A Risk-Based Approach to Qualifying Biomarker Lab Providers
Qualification of biomarker lab providers is a foundational first step to realizing the benefits of biomarkers in drug development programs. The Diligent Qualification Platform service offers an effective approach that the industry can utilize to reduce variability, costs, and cycle times and effectively manage risk in selecting and qualifying biomarker lab providers.
Some providers of biomarker laboratory services with RFI details accessible via the Diligent Qualification Platform
|Eurofins Central Laboratory||eurofins.com|
|Frontage Laboratories Inc||frontagelab.com|
|Huidu (Shanghai) Medical Sciences Ltd||huidumed.com|
|Navigate BioPharma Services Inc.||navigatebp.com|
|NeoGenomics Laboratories Inc.||neogenomics.com|
|Q2 Lab Solutions||q2labsolutions.com|
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