CONSULTANT CONNECTION – ELMS SIMPLIFIES LAB TESTING OF CLINICAL TRIALS FOR SMALLER BIOTECH ORGANIZATIONS |
ELMS in Action: A Case Study A sponsor needed to screen patients by using a proprietary assay, which was only offered through a particular referral lab in the U.S. When the referral laboratory suddenly changed their methodology mid-study, the ELMS team requested validation and correlation data. The ELMS team found that the new method would not stand up to clinical testing requirements and could potentially impact patient safety and invalidate trial data. Working quickly to implement corrective and remedial actions, the ELMS team worked with the lab to ensure that a reliable, high-precision assay was in place ‒ restoring data integrity and delivery of a regulatory-compliant data package to the sponsor. |
Solve your client’s testing challenges |
Simplify your client’s testing vendor relationships and discover a scalable way to outsource external laboratory management in this issue of Consultant Connection. |
Managing esoteric testing and proprietary assays, while ensuring global uniformity throughout a trial, is more complex than ever. Many sponsors are turning to outside vendors to handle collection, testing and data generation, but how can you help your client properly vet a potential partner and ensure they receive submission-ready data? The ideal partner for clinical testing should be able to:
Chances are, your client doesn’t have the time or resources to devote to managing multiple external laboratories. To tailor a solution for small and emerging clients, Covance created Expanded Laboratory Management Solutions (ELMS) as a novel approach to anticipating and addressing common external lab management issues.
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Sourcing, managing, and ensuring quality data from external laboratories is a costly and burdensome process for your client. ELMS is a scalable, one-vendor solution that addresses this challenge by establishing a direct connection between your client and the largest network of qualified labs. With straightforward processes to easily access more than 3,000 qualified assays within the Covance and LabCorp network – in addition to third-party lab testing – your client will receive the critical, high-quality data they need to support their studies. |
Contact Your Consultant Connectors Lecia Johnson and her team are standing by to provide consultants with seamless access to Covance global solutions – preclinical through clinical, to registration and market access. Contact us today – we look forward to helping you succeed. Contact the team > |
ELMS Resources |
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Past Consultant Connection Articles Explore more ways to advance your client's programs: |