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.
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:
Design visit-specific collection kits that minimize the burden on the patient while improving global uniformity of sample collection
Properly train investigator sites to ensure protocol compliance to avoid unanticipated delays
Direct and route samples to their destinations in a timely fashion to ultimately produce quality data
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.
Reduce management overhead: Evaluating and managing different laboratory partners and contracts to support a single trial pulls your clients away from critical research and development activities. Your client can save efforts and costs to achieve a better ROI – and meet regulatory compliance – by leveraging ELMS lab selection and management services.
Minimize lab qualification and data reconciliation efforts: Transferring and combining data from multiple labs can be an intensive, laborious undertaking that requires specific data management expertise. With a rigorous process to secure external laboratories and ensure ongoing validation of assays, your client can trust that ELMS will provide critical oversight for ongoing data quality. Your client will receive a solution designed for compliance with the ISO 15189:2012 standard, which requires oversight at each step of the process to ensure data quality will be sufficient for regulatory submissions.
Leverage the benefits of scale: With ELMS, your client can work with the central lab that manages more than half of all clinical laboratory work conducted today. In addition, your client can take advantage of the well-established relationships and processes that the ELMS team has with numerous specialty labs, many of which are in the LabCorp network.
Avoid reinventing the wheel: Running specialty biomarker and genomic testing requires deep expertise. Your client can rely on us to extend their expertise and eliminate the need to manage quality agreements, audit procedures and regulatory documentation.
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 >