Home > CRO Services > Medical Devices > Clinical Diagnostics
Medical Device Case Studies: Clinical Diagnostics
The Client
The client is one of the nation's leading clinical reference laboratories with a medium-term sample capacity challenge. The client experienced a surge in demand for a specific sample type and required additional laboratory capacity to process their biomarker samples. The requirement included running a maximum of 2,400 specimens per day under extremely tight cost and time constraints.
Technical Need
The technical challenges in measuring the biomarker were limited, so it was critical that the client had a trusted partner who met CLIA/CAP requirements and could provide the required volume of samples with timely and cost effective results. Technology transfer was also a critical issue; the correct partner needed a high level of technical competence and broad technology platform expertise.
Cambridge Biomedical's Service
We evaluated all technologies and platforms available to conduct the tests and performed GAP analyses for maximum operational efficiency. A comprehensive program was developed to train collection sites on specimen handling, including all required data reporting and documentation.
Results
Cambridge Biomedical successfully processed all samples. In addition to meeting the goals of the project, we exceeded customer expectations relative to cost management and rapid sample turnaround. Our client recognized our efforts with its highest award for partner performance.
Other Medical Devices Case Study (CRO):
