Electronic laboratory notebooks (ELNs) emerged in the R&D landscape around 15 years ago with a commendable objective: reduce or eliminate the errors and inefficiencies driven by the use of paper notebooks in the laboratory. By providing a means to capture experimental protocols, results, and research findings in digital form, organizations could, in theory, free scientists from many of the time-consuming administrative tasks associated with paper file management, enhance intellectual property (IP) protection, and provide a much easier way for institutional knowledge to be captured and retained, searched, and reused. While the general concept of the electronic laboratory notebook, however, has steadily gained traction, the evolution of the technology has resulted in two divergent paths: the highly specialized, discipline-specific ELN designed to aid a single scientific domain or process (medicinal chemistry, drug metabolism/pharmacokinetics [DMPK], or QA/QC, for example), and the generic ELN, which takes more of a “one-size-fits-all” approach.
Which ELN path to follow?
Each of the two ELN approaches has advantages and disadvantages. Discipline-specific ELNs provide customized features tailored explicitly for end users, allowing them to enter experimental information and build data work flows in a form most comfortable and familiar to them. But in order to go paperless organization-wide, a company would need to deploy separate ELNs within numerous scientific domains and departments. This is where problems may come in. Discipline-specific ELNs create “silos” of experimental information and work flows, adversely impacting scientific collaboration, data mining, and reporting across the end-to-end research enterprise. In addition, supporting multiple, diverse ELNs can also become an integration and maintenance burden, burning through IT budgets and resources.
The generic ELN—sometimes referred to as the “paper-on-glass” replacement of the paper notebook—has been presented as an alternative to the challenges of deploying discipline-specific solutions. Focused on enabling scientists to quickly capture information including structures, text, spreadsheets, and images, generic ELNs are intended to keep things simple enough that many diverse users can leverage them across an organization. These ELNs focus on a common value proposition for scientists to replace paper, share information, and protect IP. But are they missing key opportunities to drive specific productivity for specific disciplines? The needs of individual scientists are varied and complex, and if a solution does not support these needs, there is a missed opportunity for added productivity as well as a risk of low adoption and compliance. Because adoption is critical to the success of any technology deployment (especially on an enterprise scale), end users—including chemists, biologists, formulators, material scientists, engineers, and other key stakeholders within R&D—ideally should be given a tool that is not only easy to use, but also delivers capabilities and flexibility to analyze and share information in a form most suited to their unique research. What is the answer?
The best of both ELN worlds
A third approach, the multidisciplinary ELN, takes into account the advantages and disadvantages of earlier approaches. The result is a single solution that can be leveraged across the R&D enterprise, while at the same time providing capabilities that can be configured to meet the diverse needs of different scientists and other R&D contributors.
Figure 1 - ELNs can be categorized into three main types: general, domain-specific, or multidiscipline. Scientific domain capabilities vary among the different ELN focuses, which in turn reflects the depth and breadth of deployment within a scientific organization.
For example, a multidisciplinary ELN may incorporate out-of-the-box templates, extensions, and integration APIs (application programming interfaces) in order to support domain-specific instruments such as balances, pH meters, and chromatography instruments; analysis protocols; software such as laboratory information management systems (LIMS) and scientific data management systems (SDMS); and project work flows. Additional features could include things such as stoichiometric calculations for synthetic chemists, scaleup for process chemists, dose–response curve fitting for discovery biologists, and design of experiment (DOE) for engineers. More mature multidisciplinary ELNs offer extensive configuration options, as well as customization capabilities, enabling organizations to extend the ELN to suit not only discipline-specific functionality but also business-specific processes within the organization. The key is that this type of solution serves as the central system for data capture, access, collaboration, and tracking. It offers, in essence, a single environment for site-wide or organization-wide scientific productivity while delivering tools that empower (rather than discourage) individual contributors to participate (Figure 1).
Can one solution fulfill the necessary requirements when science is so diverse? Of course, some research stakeholders will have a better experience than others, but it is important to consider the bigger picture. The increasing dominance of the smartphone offers a good analogy. When compared to device-specific products, is a smartphone the best phone? Is it the best e-mail editor? Is it the best Internet browser? The answer is unanimously no. However, does it provide the best overall experience? Most users would say yes.
Every scientist benefits from going paperless with an ELN that provides work-flow-specific productivity improvements (e.g., efficient and timely documentation, easy information access, and improved IP protection). However, the multidisciplinary ELN provides the additional benefit of enabling scientists to coordinate work flows and manage information exchange across scientific disciplines. For example, a process chemist can select a set of samples for analysis within the ELN and then assign the samples to an analytical scientist for testing.
Figure 2 - A multidisciplinary ELN delivers domain-specific capabilities and connects scientists, instruments, and software together in a collaborative environment. For example, analytical scientists can work closely with process and formulation scientists while benefiting from domain-specific capabilities such as chromatography data system (CDS) and LIMS integration.
The analytical scientist receives the request electronically, completes the analysis using discipline-specific templates, and returns the summary results to the process chemist’s ELN upon completion; the entire work flow occurs within the shared ELN application. With all organizational knowledge centrally captured, it then becomes easier to collate necessary information for project reviews and regulatory compliance, and most importantly, to collaborate effectively beyond the boundaries of individual departments and scientific domains (Figure 2).
Figure 3 - ELNs previously tended to be either generic notebooks focused on a paper-on-glass replacement of the paper notebook or domain-specific notebooks designed for very specific scientific work flows. However, the newest ELNs deliver multidisciplinary capabilities designed to help multiple groups of scientists go paperless and benefit from domain-specific capabilities in a collaborative environment.
The multidisciplinary ELN thus provides benefits on an individual, project, departmental, and organizational scale (Figure 3):
- Documentation and record-keeping are simplified, enabling scientists to track who did what, how, why, when, etc.
- Project stakeholders can more easily access, analyze, report, and share laboratory data across departments and disciplines
- IT is freed from the burden of supporting multiple ELN solutions
- The organization as a whole has a single repository of IP assets and research knowledge to coordinate experimentation from laboratory to plant.
Multidisciplinary ELN for R&D
For Alere (Waltham, MA), a provider of diagnostic products and antibody development technologies, the demands of product development have prompted the deployment of a multidisciplinary ELN. The company’s solution is used by several departments within its R&D operations in San Diego, CA.
Alere, like most companies, wishes to move product development along as quickly as possible, which does not leave much time for “data handoffs.” When one department or project group needs data from another, the multidisciplinary ELN allows them to simply take what they need and run with it.
The R&D organization is highly diverse, comprising multiple specialties and focus areas spanning biology, organic and analytical chemistry, formulation, engineering, assay development, and more. The company wanted to gain efficiency through better, more consistent documentation of research; reduce redundant laboratory work; and enable easier information access, searchability, and collaboration. It was decided that cobbling together multiple domain-centric solutions would be far too costly and complicated, and thus a multidisciplinary approach was taken. Since the primary aim was to promote use across the organization and facilitate greater collaboration, it was imperative to find a solution that would work for people with diverse backgrounds.
Prior to the deployment of the ELN, departmental groups within the company’s R&D organization each relied on their own systems and processes for data capture and tracking. Some disciplines, organic chemistry being one example, were 100% paper based. This led to a large amount of administrative effort when it came time to hand off data: File drawers needed to be searched, data formatted, photocopies made, and so forth. With the ELN, however, scientists can capture their laboratory information in electronic form. When someone else needs it, all that is required to send a report is a click of the mouse, which saves much labor and time. As soon as data are entered, contributors throughout the organization have immediate access to those data, which increases collaboration. Taking away the paper burden gives the company’s scientists more time to focus on their high-value work.
Searchability is another important benefit of the ELN. Anyone in the organization can search the system for whatever information he or she is looking for, which helps reduce both administrative effort and rework. For example, when an antibody is being tested, researchers need to have intimate knowledge of the organic molecules that were used to develop it. With the ELN, they can easily search the electronic record to find out more. This eliminates the need to find out who worked on what phase of the project, then rummage through archives, storage, or shelves to locate the notebook, etc. The information is available and searchable from the desktop.
Alere’s ELN has been in production for more than a year, with 70–80 scientists across the company’s San Diego site using the system. David Arida, Associate Director of R&D Services, estimated that, from a quantitative standpoint, each user saves several hours per week in administrative time using the system, which translates to a 5% efficiency improvement across the user base. More gains are expected as the company works to extend use of the solution to more users and sites.
That is not to say that the company did not experience challenges while rolling out the ELN. Like many organizations, it has had to contend with resistance from late adopters. According to Mr. Arida, some people gravitated to the ELN right away and others were more reluctant, prompting the company to collect some performance data from the early users about how much time they were saving, how long it took to upload information, and what their experiences were in order to sell the system organization-wide.
Mr. Arida and Dr. Mariusz Banaszczyk, Senior Chemistry Manager, recommend starting out simply and taking a phased approach to system rollout, adding more departments and domains as scientists become accustomed to working with the ELN. They also advise organizations to consider how much time will be needed for training, system maintenance, and troubleshooting. Mr. Arida stressed the need to have a clear vision of where the company is at the present, what updates its employees are likely to adopt, and where the organization is headed in the future, indicating that with a well-thought-out, realistic plan, the path forward will be clear.
Customized user templates in multidisciplinary ELN
The ability to customize document work flows and data entry templates for individual scientists was key to the success of a multidisciplinary ELN deployment at Millennium Pharmaceuticals (Cambridge, MA). The leading biopharmaceutical company is leveraging an ELN across its entire nonregulated discovery organization, encompassing 150 scientists and nine functionally different research groups. While each group maintains its own work flows and processes, the data they generate have become accessible to all members of the discovery organization.
The company’s Cancer Pharmacology and Molecular Biology groups, for example, use the ELN to perform related experiments as part of a larger study. The scientists in each group are able to create permanent links between related experiments and instantly jump between records. Additionally, Millennium scientists can reference entire sections of other experiments from within the ELN. The reference presents the data, procedure, or conclusion in a new ELN record while maintaining a link back to the original document. These features are especially valuable because they make data easier to access and share across the organization, while still allowing scientists to retain their own discipline-centric work flows and data handling processes.
According to Dr. Gabriel Weatherhead, Lead Systems Engineer for research and development systems, the customized templates reduced the friction of using the ELN and enabled an increase in policy compliance and scientific collaboration. Rather than maintaining separate ELN products and environments, the company took a multidisciplinary approach to encourage data sharing among its many departments.
Benefits in project reporting and coordination have also been realized. For example, users may query and report on experiments pertaining to a single project from multiple departments. The company additionally developed customized document work flows that allow scientists to contribute information to a single document while maintaining a complete record of all individual changes. Although this customization was well worth the effort, it did require some advance planning. Accurate use cases were critical to developing templates that address both the needs of individual users and cross-functional groups.
Dr. Weatherhead noted that although the end-user customizations required significant time investments, in the end they reduced the technical barriers to the company’s ELN adoption, giving scientists a rich experience that also encourages greater sharing and collaboration. He added that the investment was worth it, since the company realized significant gains in return.
Conclusion
Today, visionary scientific organizations are starting to take notice of the multidisciplinary ELN. The next-generation technology presents new opportunities for collaboration and information management across the scientific enterprise, but organizations also need to do their homework before jumping into a deployment. A comprehensive, clearly defined strategy will help ensure that companies make the most of their software investment. As paper-based laboratories rapidly become a thing of the past, the multidisciplinary solution offers a compelling choice for organizations seeking to combine the best of the ELN world.
Dr. John is Product Marketing Director, Accelrys, Inc., 10188 Telesis Ct., Ste. 100, San Diego, CA 92121, U.S.A.; tel.: 858-799-5000; e-mail: [email protected]. Dr. Banaszczyk is Senior Chemistry Manager, Alere Inc., Waltham, MA, U.S.A. Dr. Weatherhead is Lead Systems Engineer, Millennium Pharmaceuticals, The Takeda Oncology Company, Cambridge, MA, U.S.A.