Many institutions have biorepositories spread throughout multiple research centers or medical facilities. They are often found using differing solutions within each lab such as excel, homegrown databases or LIMS tools. Given the differing data elements and formats, data may be exchanged through email, thumb drives, or pushed to a folder on a local server.
When it’s time to scale to the enterprise and share accessing biospecimens and associated data, there are plenty of LIMS and biobanking vendors out there selling the software. However, the software product is only one piece of the puzzle. In order to make it effective for the long run, and a reliable service to researchers, the institution must consider the following:
1. Business Workflow
Analyze the workflow between departments using business process modeling before diving into the product.
How are biospecimens collected, stored, requested and distributed?
Which stakeholders are involved in these activities?
What are the stakeholder’s needs downstream with regards to biospecimens and associated data?
It is important to evaluate the as-is processes against the product’s capabilities to define a to-be workflow that fits the overall purpose. When looking at the enterprise, the business processes for storing and accessing biospecimens need to align across multiple facilities or labs.
While designing a to be process for your institution takes precedence, some compromise is needed here from both the customer and vendor. Insisting on a specific business workflow can require expensive customization of the product and lengthy rollouts. A rigid workflow model from a product may require large business process changes and re-training across the board. Evaluate products that are aligned with good biobanking practices and are built to be CFR Part 11 compliant.
2. Best Practices
The lack of high-quality biospecimens has been recognized as a blocker to research. The requestor has to trust the source biospecimen and its associated data to ensure quality research results. Biobanking best practices such as those fromNCI Best Practices for Biospecimen Resources must be consistent across the board to ensure quality of the specimens. This will require a review and governance of biobanking procedures (e.g. consent, collection, processing, storage, request, distribution) to incorporate the software as a part of the process, along with training.
3. Data Standardization and Data Sources
Accessing specimens and data from multiple sources starts with consistency across the biobanks. Global terminology standards relevant to biobanking include the Common Biorepository Mode from NCI, LOINC, ICD-9/ICD-10, and SNOMED-CT. If the institution has a data governance group or committee, it is best to align with this direction on vocabularies to ensure interoperability with existing and planned data sources. If not, have a plan to get there.
As the use of the biobanks increase, access to related clinical data is desired from various source systems (e.g. Pathology, Clinical Research Management Systems & Clinical Data Management Systems). This data must be mapped and related to the biospecimens. A data warehouse can act as the broker for mapping the multiple data sources to a set of standards for the enterprise.
Overwhelming? Don’t panic, avoid analysis paralysis, and phase it in over time. Start small and allow plenty of time for piloting to adjust before rolling it out to the enterprise.