Biobanks are playing a crucial role in biomedical advances globally. They are quickly gaining importance for translational research, new drug discoveries and drug development, which are crucial elements for delivering personalized medicine. It is the new era of medical research that has brought in new discoveries, new knowledge on biological processes, and a wealth of information related to health and diseases. Specifically, treatments for cancer, neurological and metabolic diseases are on the agenda of personalized medicine for which biobanks play a pivotal role in providing and stratifying biospecimen that enable such research.
Carrying research in personalized medicine or developing novel drugs, needs human biological samples. These samples are collected, stored, shared, and provided for research purposes. Until the last decade, there were no predefined set of rules and regulations for collecting samples. Moreover, biobanks did not have to associate each sample painstakingly with patient-related attributes. Today, owing to strict regulatory compliances, the process of associating patient data with samples stored in biobanks includes clinical, demographic, lifestyle, and environmental information. This recording of biological samples generates a lot of data necessitating an informatics system that enables efficient and secure handling of sample and patient-centric information. How do you organize such a large dataset? The solution is offered in the form of a LIMS – Laboratory Information Management System. However, it raises a couple of questions. Can a LIMS software adequately respond to specific biobank features and functionality? What are the differences – if any – between a LIMS for laboratories and IT systems for biobanks?
LIMS manages the tests performed on samples and tracks them throughout the testing process. LIMS designed for biobanks can trace sample origins, their storage location, and the change in custody when accessed by different members of the laboratory. Today, several criteria for sample storage and management are regulated in the form of HIPAA and 21 CFR Part 11 guidelines – which a LIMS needs to follow. Additionally, there are a few requirements that a biobank LIMS software should fulfill to seamlessly handle samples and their associated information efficiently and securely. These are:
- Manage storage locations throughout the workflow, including volume tracking and the chain of custody, complete with electronic signatures
- Manage temporary and transit storage locations and report the full account of transfers, custodian and location changes
- Manage and record complete genealogy by tracking aliquots, derivatives and pooled samples
- Manage complex biographical information of each sample donor
- Handle the consent process
- Maintain a centralized system that controls data extraction from several sources and documents, otherwise available in an unstructured format
Other features, particular to biobank workflows, are sharing of sample information, and test results. This sharing is possible between researchers located at different geographic locations. Advanced software architectures have evolved in the form of web-based platforms/software that enable users to search samples, related attributes applicable to a specific demographic population, thereby enabling longitudinal studies such as disease monitoring, aging studies, and biomarker discovery.
The increasing demand for collecting huge volume of data of sample donors, for personalized diagnostics and therapeutic measures, creates challenges for the storage space. Stand-alone systems don’t have the capacity for storing large volumes of data and in some cases, old records must be deleted to generate space for the new incoming data. This results in loss of valuable information (usually historical data) which can be relevant and valuable for future analysis.
Is there a solution to this problem? Cloud is the answer – as the data gets stored in a virtual space instead of institutional hardware. Cloud computing, often referred to as simply, “the cloud,” is the delivery of on-demand computing resources—everything from applications to data centers—over the Internet on a pay-for-use basis. This delivery model ensures no data loss or breach if the hardware is stolen or lost. In addition to solving the storage issue, a cloud-based LIMS offers something more, which can tremendously benefit small to mid-sized laboratories. Cloud is an affordable solution, which eliminates the budgetary concern of every lab. There are no hardware costs, and lab spends on maintenance and recruitment of IT staff. Backups are ensured by the service providers. Cloud services grant flexibility to access data in real time from anywhere, 24×7, 365 days a year. Users can access data using internet enabled devices such as a tablet, mobile phone, laptop, or a personal PC. Data transmission is secure via encryption mechanisms and data storage is secured using access permissions and log-ins. Cloud-based biobanking LIMS enables biobanks, clinical and testing labs to focus on research rather than spending time in managing data, IT resources and software purchases.