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BioReliance offers additional clinical trial support
services to sample analysis. These services include:
Potency assays are required for most biological products and form part of a panel of lot release assays. Potency assays can be validated for accuracy, linearity, precision, range, limit of detection (LOD), limit of quantification (LOQ), repeatability, and robustness. We have experience in performing potency assays for the cGMP release of licensed biological products.
The assays used for sample analysis depend on the vector used. We work with the sponsor by using pre-existing established assays, developing new assays, or transferring assays from the sponsor. For more information on this offer or to discuss the specific requirements for your studies, please contact us.
Sample container delivery to clinical sites worldwide;
Logistical support for the global collection and cold shipment of
samples; Clinical sample receipt and storage at –70°C
These services are supported by our experience and resources to handle large numbers of samples as well as the ability to ship containers and collect samples from sites worldwide. Our labelling system has been devised for accurate tracking of samples through collection, storage and testing and our Patient Sample Collection Forms ensures that we have the necessary sample information for accurate testing and reporting.
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