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Pre-Clinical
The Client
A leading CRO that was retained by a biopharmaceutical company requested Cambridge Biomedical's assistance to identify and develop an assay to provide accurate and repeatable results of a biomarker in two body fluids.
Technical Need
Quantifying a biomarker in two distinct body fluids was the key technical requirement. Cambridge Biomedical met with the end client and helped to determine the ideal assay for the study.
Cambridge Biomedical's Service
During the assay transfer and evaluation phase, it was determined that the recommended assay sensitivity required improvement to meet the trial requirements. We proposed modifications to the assay method that were reviewed and approved by the client. Cambridge Biomedical then validated the modified assay and ran the samples, providing the CRO and its client with the necessary data to complete the Phase I trial.
Results
Cambridge Biomedical's efforts improved the original FDA submission with enhanced assay robustness and detailed documentation. Subsequently, the biopharmaceutical company asked us to utilize the same methods to validate the results of their original IND submission.
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