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), 21CFR 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 organisations 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 these diverse challenges, LabVantage has created the Sapphire Biobanking Solution. Developed in conjunction with the original developer of the Spectrum specimen management system, Sapphire Biobanking Solution 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 organisation-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.
Sapphire Biobanking Solution’s key functionality includes:
1. Supporting GLP Operations
As a 21 CFR Part 11 enabled system, Sapphire maintains the segregation between GLP and non-GLP materials, laboratories and storage locations. Designed to meet FDA requirements for sample identification and integrity, Sapphire tracks the segregation of GLP and non-GLP storage and samples, allowing companies to confidently combine their clinical and non-clinical infrastructure.
2. Complying with Regulatory and Legal Requirements
Samples collected in patient registries and biomarker studies can be governed by narrow consent and contractual restrictions on their use, even for discovery based pharmacogenomics.
3. Managing Complex Biographical Information
Sapphire’s robust data entry workflow collects and verifies 'biographical' information about each received sample.
4. Tracking Chain of Custody
Transfers between groups are recorded with tracking numbers and electronic signatures.
5. Utilizing Various Storage Containers
Sapphire manages temporary and transit storage locations and reports a complete history of transfers, custodians, and location changes.
6. Managing Complete Genealogy
Aliquots, derivatives and pooled samples are fully tracked within Sapphire, which records acomplete sample genealogy for each sample.
7. Recording Final Disposition
The status of final disposition of each sample is registered within Sapphire with an electronic signature.
8. Ensuring Appropriate Restrictions
Each study can define one or more 'restriction classes', each representing a particular type of consent or legal obligation relevant to that study.
9. Tracking with Bar Codes and RFID
Sapphire supports barcode or RFID symbology, which reduces the need for keyboard entry.