A good CRO partner should have expertise in method development, which can be evaluated through incurred sample reanalysis. Incurred sample reanalysis is useful to demonstrate method robustness and analyst execution and may highlight unstable metabolites that would not be present in laboratory prepared QC samples used to validate the method.
In addition, the CRO should be able to prepare qualified Standard for Exchange of Nonclinical Data (SEND) data packages, which is a critical attribute of an effective global CRO partner. The SEND is a more recent initiative from the US Food and Drug Administration (FDA) intended to standardize nonclinical data packages based on Clinical Data Interchange Standards Consortium (CDISC). The current FDA approved SEND guidelines are required for applicable Nonclinical studies that were initiated after Dec 17, 2016.
Finally, the CRO should be a stable and reliable partner in the drug development process, from initial drug development process, through non-clinical toxicity studies, and into late-phase clinical trials.
This webinar will include an overview of a case study as well as a Q&A session with the featured speakers.
For more information or to register for this event, visit 3 Attributes of a Great Bioanalysis CRO Partner.
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