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In the second part of this series helping researchers determine whether a LIMs or an ELN is right for them, Barry Bunin, CEO Collaborative Drug Discovery, continues his guide to understanding what a LIMS is and how it differs from other scientific data management systems. Read Part 1 here.
Pharmaceutical labs often run a variety of high-throughput workflows that can involve multiple instruments, samples, and datasets. A single pharma company may house a range of laboratories operating at any given time, each with its own unique workflows, and handling everything from research and development and compound testing through to manufacturing. Furthermore, pharma companies are under increasing pressure to produce drugs more efficiently and within a shorter timeframe.
A laboratory information management system (LIMS) can help improve efficiency and productivity through standardised and automated workflows and centralised data and instrument management. In the competitive drug discovery market, labs can be confident of the security and safety of any intellectual property stored in their LIMS. They can consolidate their reporting using these systems and ensure that their protocols and workflows hold up to regulatory scrutiny. Because LIMS vendors make it their business to stay abreast of technological developments, labs can adopt improvements in LIMS technologies relatively painlessly. Lastly, the easily customisable nature of LIMS makes them an attractive option for pharma companies seeking a single solution that, with some tailoring, can work for all their labs.
Do you need a LIMS?
Given the investment involved in implementing new infrastructure, some labs may be on the fence about getting a LIMS. But the return on investment that these systems offer over time can’t be overlooked. There are some helpful tools for starting the process of computing what those numbers might be like this white paper from BioSoft Integrators1 on how to determine the ROI on LIM investment. It is useful for labs that are seeing increasing sample volume or looking to expand the kinds of experiments they offer to clients. In a world where time is money, LIMS help labs avoid wasting precious resources tracking down missing datasets or correcting errors in reports.
Before investing in a solution, it is important to think about exactly what functionality is needed in the lab. If the primary need is a tool for sample management and tracking, then a LIMS solution may be the best option. However, if what is really needed is a tool to manage unstructured lab data or track chemical compounds, then an electronic laboratory notebook (ELN) solution or even a compound registration software might be a better fit. As noted, pharma companies often have multiple labs operating in-house. Depending on the needs of these different research groups, it might be useful to consider purchasing an integrated platform that offers combined access to a LIMS, ELN, and compound registration solutions.
Commercial vs homegrown LIMS
Different LIMS are designed to meet different needs. For example, one lab may need a system that offers significant data management functionality for handling data of different types. Another lab may need something that integrates functionality from multiple solutions such as a platform that combines the features of an ELN with LIMS.
Labs considering LIMS solutions have their pick of companies selling hosted and/or on-premise solutions. And today’s vendors have come up with creative ways to position their solutions. The one you pick will depend on your lab’s needs, number of users, and price point among other factors. Moreover, some LIMS solutions are developed for clients in specific market segments that have unique needs such as molecular diagnostics labs.
Most commercial LIMS today can be configured to meet individual customer requirements and are easy to use. These solutions work well with many of the common instruments found in pharmaceutical and other kinds of labs. The exact price points and subscription models vary from one vendor to the next. Different systems also require different kinds of infrastructure in order to run. Some of the systems currently available in the market include: BaseSpace Clarity LIMS, LabWare LIMS, Sunquest Mitogen LIMS, STARLIMS, LabVantage, Exemplar LIMS , Core LIMS, SampleManager LIM, and SLIMS.
Some commercial platforms combine multiple functionality. For example, the LabVantage system combines the functionality of LIMS with those of an ELN and a Laboratory Execution System. For its part, Exemplar LIMS combines LIMS functionality with ELN and Scientific Data Management System capabilities. Lastly, SLIMS, which is developed by Agilent, integrates LIMS and ELN functionality.
In addition to reviewing the available solutions on the market, there are some labs that opt to design and develop their own LIMS in-house. Armed with the right programming team and a detailed listing of the lab protocols and workflows, it’s certainly possible to craft a system that will be uniquely tailored to the needs and specifications of the lab. It may even be less of a financial burden to develop a system internally than investing in a commercial option.
But programming a LIMS takes time and requires an almost encyclopaedic knowledge of the lab’s workflows and protocols to properly develop the needed functionality. Moreover, lab needs may change all the time and technological developments happen quickly. By the time the system has been built, it may already be outdated. Moreover, the lab and its programming team have sole responsibility for maintaining the system and fixing it when something breaks. There may also be challenges with getting different pieces of software to talk to each other let alone the other instruments in the lab.
Labs may also run into problems if the programmer or programming team turns over and takes their knowledge of the system with them. Lastly, regulated labs that decide to make their own systems will have to shoulder the responsibility and costs of going through any appropriate validation processes and approvals required by regulatory authorities in their field. Getting systems approved in this context is both time intensive and difficult. What started out as a cost saving strategy may end up being prohibitively expensive.
Important Considerations
Whether the goal is to purchase a LIMS for the first time or to transition from a legacy solution to a newer, more advanced one with greater functionality, there are a few things to think about:
Financial and time considerations: One of the bigger barriers to getting a LIMS may be the cost. Once the decision is made to invest in a system, there are costs associated with deploying the system, licensing fees, customisations to meet the needs of the laboratory and workflows, ongoing technical support, and ongoing system maintenance. There’s also a significant time investment in getting staff trained to use the platform and moving existing data into the new system. These costs may end up being worth it to the lab in the long run, but the initial investment can be quite steep. The quickest way to become frustrated is to have an expensive system lying dormant because the funds for its upkeep ran out. Or to have a system that’s not used enough to justify the expense. For small to mid-sized laboratories, cloud-based solutions may be a better fit from a cost perspective. Lastly, limiting customisation to only essential protocols can be an effective cost cutting measure, but it does mean that there may be some manual steps that the lab will still have to do.
Features: The list of commercial LIMS solutions provided above is by no means exhaustive. There are many more systems of the market each offering their own rich set of features and functionality. Identifying the right combination of features for a lab’s needs can be challenging and overwhelming. The best tactic for avoiding confusion is to list all desired features and functionality before starting to explore available options. This helps narrow the field of feature options and ensures that the lab isn’t swayed into purchasing extra functionality they don’t really need. This also helps the lab avoid purchasing a solution that isn’t the right fit for the task, for example, buying a LIMS for managing unstructured lab data when what is really needed is an ELN.
Creating a features list is also helpful for comparing different solutions on the market to identify the best fit for a given lab’s needs. Some vendors offer checklists that can be used to help labs assess whether their LIMS is a good fit.
Buy-In from management and laboratory staff: Approaching management with a request to invest in a LIMS solution is necessary for securing a budget and long-term support for the infrastructure. But equally important is ensuring that the people who will use the system on a regular basis are aware of the proposal. Basically, there should be consensus in the lab about the value of the system, the decision to purchase a particular system, and the team should be willing to use it once it has been installed. It is important for lab managers to allow their teams to share concerns about the new infrastructure as well as any previous experiences with LIMS. All of this is valuable information that can inform the system that is ultimately chosen. It will also help make the transition smoother because staff can think through how their job responsibilities and daily tasks will change once the system is implemented.
Not a perfect fit: Though LIMS solutions are becoming increasingly technical and intricate in their features, these systems may not perfectly match all the lab’s needs. Vendors can make customisations but there is a limit to how much flexibility these systems can tolerate since different labs have unique requirements and analysis specifications. Even within the same company, labs may be using the same LIMS in different ways. Changes will need to be factored into the costs of the system and can extend the implementation time of the system significantly.
Conclusion
LIMS can be a valuable addition to any lab but particularly labs that work with large numbers of samples and data. Not only do they improve operational efficiency, they also reduce risks of human error and ensure that the integrity of samples and any associated data is maintained throughout the lab process.
Keep in mind though, that the world is different today from when the early LIMS were first developed and used. Much of the functionality that exists in today’s systems evolved organically out of industry need while other types of systems like ELN, LIS, and compound registration offer alternative approaches to managing laboratory data. Instead of getting overwhelmed with choices, it’s important to have a clear picture of the essential functionalities you are looking for and find the system that matches your needs.
Volume 22, Issue 4 – Fall 2021
About the author
Barry Bunin, PhD is CEO of Collaborative Drug Discovery, provider of the CDD Vault research informatics platform. Prior to CDD, he was an Entrepreneur in Residence with Eli Lilly & Co. Dr. Bunin is on a patent for Carfilzomib, a protease inhibitor drug for the treatment of multiple myeloma.
References
- https://biosoftintegrators.com/wp-content/uploads/2020/02/WP_LO_ROI_05102018_01.pdf
