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.
