
Many organizations have to deal with the heightened regulatory and privacy compliance demands of Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), 21 CFR Part 11, HIPAA and IRBs. For this reason, the LABVANTAGE Biobanking Solution enables centralized biological specimen tracking from “cradle to grave” to comply with all of these standards and requirements. In addition, it satisfies patient consent requirements, enhances scientific data accuracy, and improves product development efficiency. The LABVANTAGE BioBanking Solution covers everything organizations need during the discovery process for pharmacogenomics and pharmacoproteomics.
Some key features the LABVANTAGE BioBanking Solution offers are its intricate chain-of-custody functionality, its organization-wide inventory control, and its ability to track the genomic and phenotypic data associated with biospecimens. The solution also has elements that render it unique; for example, if a sample is destroyed, consumed or missing, a status is registered within the system with an electronic signature. Or if a sample is collected, the solution automatically provides a “consent manifest” to each user of a material, indicating the activities on each sample, with restrictions recorded for every sample. Each study can define one or more “restriction classes,” which represent a particular type of consent or legal obligation relevant to that study.
Finally, one of its best qualities is that it can facilitate the sharing of information across multiple laboratories, between employees and customers. To make this exchange of information easy, the LABVANTAGE BioBanking Solution is entirely browser-based and is loaded on a central application server – not individual PCs – that can be accessed by users through the Internet or Intranet via most browsers from any wired or wireless device. Project level decision-makers external to the lab or biorepository can access dashboards and view reports, which increases visibility throughout the entire lifecycle and expedites decision-making processes.
LABVANTAGE offers a complete Biobanking solution for your organization.
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