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One of the key issues facing biotechnology and pharmaceutical companies today is the complexity of managing the increasing number of bio-specimens (tissue, blood, DNA, RNA, etc.) generated during the clinical trials process. With heightened regulatory and privacy compliance necessitated by Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), 21 CFR Part 11, Health Insurance Portability and Accountability Act (HIPAA) and Internal Review Board (IRB) requirements, a solution that accurately tracks patient consent, HIPAA waivers, laboratory conditions, and electronic signatures is critical. Furthermore, as organizations recognize the additional value of utilizing samples during the discovery process for pharmacogenomics and pharmacoproteomics, solutions need to be able to easily store, locate, and access vital biospecimens along with critical genomic, proteomic, and phenotypic information without difficult system integration.
Recognizing the diverse challenges of running a successful and efficient biorepository, LabVantage has created the Sapphire Biobanking Solution. Developed in conjunction with the original developer of the Spectrum™ specimen management system, the biobanking module addresses the need for data capture, location management, handling assurance, and operational efficiency required to manage a biorepository at any organization.
Sapphire enables centralized biological specimen tracking from "cradle to grave" to comply with GLPs & GCPs, satisfy patient consent requirements, enhance scientific accuracy, and improve development efficiency. Whether storing or tracking whole-blood, tissue, cellular lysates, DNA, RNA, proteins, etc, Sapphire supports organization-wide inventory control. Sapphire offers intricate chain-of-custody functionality, including detailed location & shipment management, aliquot/derivative & pooled sample tracking, and electronic signature captured transfer & disposition. Moreover, as an integrated solution, Sapphire enables organizations to track the genomic and phenotypic data associated with these biospecimens under compliance with HIPAA and other privacy laws.
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