The strategic and business importance of laboratory data has evolved tremendously over the past 25 years. Since the introduction of laboratory information management systems, laboratory staff has shifted their expertise from manual and time-consuming activities to more sophisticated data analyses. In addition, the increased role of laboratory informatics in achieving strategic corporate objectives (such as decreasing product time to market and ensuring regulatory compliance) is an indicator of how integral the laboratory has become to the overall operations of the business.
One of the most important areas of change can be illustrated in the way people work with each other, whether it involves scientists in the same laboratory or in remote parts of the world. The evolution of collaborative methods has been enhanced by the technologies available, giving the field of informatics a new role to play in bringing scientists together. And, as instrumentation has become more sophisticated, the amount of data has grown tremendously, giving today’s scientist a new challenge—managing all of those data.
Twenty-five years ago, the laboratory was essentially managed by manually recording data in the laboratory book. The introduction of the LIMS helped laboratories move past this paper-based approach to an electronic system that drives a collaborative laboratory process, confirms results, and makes those results and the information they represent available to the business as a whole. Likewise, instrument software such as chromatography data systems (CDS) has helped eliminate the manual processes formerly used to record instrument data. Scientific data management systems (SDMS) and document management systems (DMS) have helped secure the exchange of data and documents, and have reduced the laboratory’s reliance on storage rooms filled with filing cabinets and boxes. To bring us full circle, today’s sophisticated electronic laboratory notebooks (ELN) provide the electronic answer to the scientist’s historical companion—the paper laboratory notebook.
Informatics is now a critical part of the laboratory process. Compared to earlier years when instruments and databases were primarily standalone installations with their own distinct purposes and work flows, today there is increasing pressure on the laboratory to connect systems in order to harmonize processes and make use of all of the data being generated. It is now more important than ever for scientists to be able to share data and collaborate on findings.
With the introduction of each of these electronic solutions, laboratories have gained additional benefits over their paper counterparts. Perhaps the greatest of these, and one that is often unrealized, is the ability to pass information between these systems, connecting every aspect of an organization—from its operational activities to its intellectual property. Like the paper solutions in the laboratory of 25 years ago, each of these solutions has a place, but they gain the most value if they are fully integrated with each other, and with the enterprise systems that bring real-time information to management at all levels of the organization.
Research and development laboratories
Drug research and development organizations are incredibly dynamic environments that need to foster innovation and allow scientists to quickly design and execute new experiments—especially when novel insights and correlations are discovered. Research systems seek to put valuable data, information, and knowledge into the hands of the innovator. This is a very challenging task, and one may argue that technology can sometimes create a more challenging environment by adding more samples, results, projects, and collaborators to the researcher’s work day. As specialization and business processes have been optimized, numerous people are involved in each aspect of the experiment. In order to interpret the data and make their experimental decisions, researchers need to bring multiple streams of information together into a coherent story. Today, research organizations are also confronted with the additional challenge that much of that information originates at other facilities that are outside of their control, whether it is a contract research organization, the clinic, or with an academic partner.
The result is that research laboratories have extremely complex sample-tracking needs. For example, research organizations need to track not only the location of samples and their aliquots down to the individual plate well, but also ancillary information such as patient demographics and consent records. Once results are generated, scientists need to see those results through the entire sample hierarchy. The ideal LIMS solution for a research organization is a flexible system based on work flows, to which new experiments can be added daily in a very graphical and straightforward manner. A LIMS can drive the process of the laboratory; for example, it will step samples through a multistage, high-throughput screening, sending samples that pass to be split onto a new plate and to the next experiment. LIMS have centralized the sample and results data into a system that can be accessed by all of the key collaborators (see Figure 1).
Figure 1 - Electronic laboratory notebook outline.
Many laboratories still use paper notebooks to document the unstructured context and observations that accompany daily work in the laboratory. Researchers have an additional obligation to document their discoveries because the legal record is still the signed laboratory notebook. Company policy and accepted laboratory practices outline the information that must be included in the experimental record. The technology does not make this easy because, though each system is computer based, the systems are often in different data formats with proprietary file outputs. For many researchers, the documentation of laboratory records is an exercise in scissors and tape. These systems are not connected, and since the data and information are heterogeneous, spreadsheets are used to merge and transform the package into a sensible presentation, then print, cut, and tape. The end result is that electronic information is then manually transferred back to paper format. By replacing paper notebooks with an ELN, researchers can electronically capture their experimental record, from initial experimental design and hypothesis to conclusion. By connecting an ELN to a LIMS, the researcher can obtain a complete picture of the experiment and its results.
To effectively advance innovations through the laboratory, research demands an integrated strategy across ELN, SDMS, and LIMS. Researchers are all too aware that their information is the intellectual property of the company. Today’s failed compound may give them the insight they need to make tomorrow’s successful one. By connecting the separate informatics applications, researchers are able to collaborate with colleagues around the globe and with contract research organizations (CROs), academia, hospitals, and joint-venture partners, taking advantage of the electronics evolution in the laboratory.