the data generated will stand up to regulatory scrutiny, the Covance Expanded Laboratory Management ... the quality syst
IS YOUR REFERRAL LAB READY TO PERFORM YOUR TESTING? ELMS Makes Sure the Answer is “Yes” Clinical trial complexity is increasing, and with increased complexity comes the need to perform a greater variety of biomarker testing with each trial. Covance Central Laboratory Services (Covance CLS) has responded to the need for expanded testing by maintaining an in-house assay menu now containing more than 700 tests at any one time, which addresses the majority of testing required for most clinical trials. Despite this comprehensive in-house menu, more than a third of the clinical trials we perform require at least one test that isn’t currently performed in-house. To ensure that external testing is performed in accordance with our rigorous standards and that the data generated will stand up to regulatory scrutiny, the Covance Expanded Laboratory Management Solutions (ELMS) team oversees work performed outside the confines of our own labs. ELMS doesn’t just measure performance during the study, but also does a thorough vetting before the work even begins to verify that the lab is qualified to perform the testing required by a protocol. In this case, a sponsor was working with Covance and requested a specific external lab be used for two cancer-related biomarker tests that were to be performed during the trial.
Understanding the Challenge ▶ A clinical trial required two specific biomarker assays, which only a few laboratories performed ▶ T he sponsor stipulated that a specific lab be used and Covance was not aware that this lab performed the required assays ▶ Tight timelines for study initiation meant Covance needed to expedite the lab startup process
Validating Lab Readiness The short list of labs that could perform the required biomarker tests included two laboratories with which Covance, through ELMS, had done extensive work in the past. Due to previous experience, Covance understood the quality systems of these labs and knew they had a track record of performance that met clinical trial standards. Nonetheless, the sponsor felt strongly that their preferred laboratory should be used instead. As Covance was less familiar with the requested lab, there were concerns about the tight timelines involved in getting the study up and running. Covance worked quickly to execute a Master Service Agreement and put an Individual Project Agreement into place that allowed the program to quickly move forward. A key function of ELMS, with regard to oversight of the QA team, is auditing laboratories when placing new types of work and at periodic intervals thereafter. Audits are performed by a third party so that an unbiased view of the laboratory readiness can be provided. This enables a scalable solution for lab qualification and helps ensure data generated during the trial will comply with ISO 15189:2012 guidelines.
The sponsor-chosen laboratory failed the third-party audit. Despite assuring us of their readiness to perform the work during the course of several discussions, the sponsor-chosen lab had not even purchased the required instrument. Purchasing the instrument, installing it and validating the necessary assays would cause a significant time delay. This information was not disclosed prior to project initiation and came to the attention of Covance only as a result of the audit, a required part of the ELMS process.
ELMS Provides a Dependable Solution As a result of the failed audit, the sponsor reconsidered using this laboratory for their work and reached out to the Covance ELMS team for alternatives. The ELMS team had previously identified two labs that were fully qualified to perform the work on timelines consistent with our sponsor’s needs. While the ELMS team can identify laboratories and perform the needed qualification and monitoring, the selection process always includes sponsor stakeholders – most notably quality and scientific resources. After the lab options were presented, the sponsor made a final determination based on the combination of previous experience with the labs by Covance and their scientific review of the labs’ capabilities. Ultimately the sponsor selected one of these labs to perform the work. In this case, the sponsor summed up the process with this quote:
“Working through Covance gives us an added layer of expertise and protection on some of our most complex work.” Meeting the Milestones for On-time Study Startup The sponsor was able to proceed with the trial, including the critical two biomarkers, without missing any milestones, due to the proactive work by the ELMS team. Because of the extensive experience of Covance CLS, the ELMS team has deep expertise in managing biomarker trials at external laboratories. In addition to relationships with the LabCorp Specialty Testing Group facilities, Covance CLS has worked with dozens of other laboratories that have served the testing needs of our sponsors for decades. With ELMS, Covance CLS assumes ownership of data quality, as dictated by ISO 15189:2012, and becomes the hub for all of the clinical trial testing. This simplifies the operational model as well as the data reconciliation and verification pathways. ELMS focuses on delivering quality results and greater economies of scale, allowing sponsors to hand off lab performance monitoring so they spend fewer resources on the management of external labs and devote more time to focusing on moving their drug candidate and upcoming milestone achievement.
Learn more about our drug development solutions at www.covance.com Covance Inc., headquartered in Princeton, NJ, USA is the drug development business of Laboratory Corporation of America Holdings (LabCorp). COVANCE is a registered trademark and the marketing name for Covance Inc. and its subsidiaries around the world. The Americas +1.888.COVANCE (+1.888.268.2623) +1.609.452.4440 Europe / Africa +00.800.2682.2682 +44.1423.500888 Asia Pacific +800.6568.3000 +65.6.5686588 © Copyright 2017 Covance Inc.
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