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Electronic Laboratory Notebooks Enter Mainstream Informatics

Tue, 09/30/2008 - 12:10pm
Michael H. Elliott
Electronic Laboratory Notebooks Enter Mainstream Informatics

Expanding beyond the boundaries of research, ELNs automate development, quality, engineering workflows



Electronic laboratory notebook (ELN) technology, used only by early adopter and technology enthusiastic end users as little as five years ago, has risen to become a
User-reported levels of ELN resistance
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Figure 1: User-reported levels of ELN resistance
mainstream laboratory informatics platform. Expanding beyond the boundaries of research, ELN is successfully used for the automation of application workflows in development, quality, engineering and other domains. After moving beyond the implementation hurdles of cultural adaptation, organizations are realizing benefits of better data access, enhanced data quality, knowledge capture and reuse, superior intellectual property protection, and gains in laboratory effectiveness.

There are many different flavors of electronic laboratory notebooks on the market to document experiment design, execution and data capture. Some of these include products targeting specific application processes like those found in synthetic chemistry or formulations. Generic products also are available to facilitate a cross domain knowledge management strategy. Off-the-shelf technologies, like Microsoft Office SharePoint Server (MOSS), are increasingly being utilized as foundations for internally developed ELNs.

Atrium Research defines an ELN as “a secure system assembling scientific content from multiple sources related to each other, allowing for contextual annotation, and packaging it in a legally acceptable document to be searched, mined and collaborated.1” As with any general definition, this is subject to interpretation. A genomics scientist who requires a free-form research platform will view an ELN quite differently than a quality manager who has the need of a very structured system to guide technicians through pre-approved methods. Just as with LIMS, there are plenty of suppliers to choose from; what system you might need depends on your organization’s goals, objectives and processes.

The ELN market
In August of this year, Atrium Research published the results of its 2008 ELN survey2. The objective of the study was to provide a quantitative and qualitative examination of the current ELN market and trends through a survey of potential users and existing customers in select industries. Over 500 scientists, managers, and information technology personnel from 23 countries participated. This is the third year of the study enabling year over year trends to be examined and analyzed.

Laboratory personnel continue to be confronted by the ever-growing amount of data and information being generated. Over 90 percent of the survey respondents report various data management challenges such as locating information, data consolidation or keeping up with the expanding data volume. Nearly identical to the results from our 2006 survey, these frustrations cross all markets and scientific domains. The top five challenges across all work areas are:

1. finding data and information when it is needed
2. storing and organizing data
3. sharing data with others
4. using too many systems and databases
5. keeping up with the growing volume of data

As expected, there are slight differences between R&D and QA/QC. For example, QA/QC feels a greater burden of consolidating data from various sources.

Interestingly, the vast majority of LIMS and ELN users express the same data management challenges as non-users. This illustrates how these technologies are just components of a larger informatics puzzle. Unfortunately, there is no single comprehensive solution available to all the data management requirements in the laboratory due to the diversity of data types, multitude of application processes and fragmentation of the supplier base. Over 90 percent of prospective ELN users feel they will have to integrate data from multiple systems.

Over a quarter of the potential laboratory market has now implemented (or is in the process of implementing) an electronic lab notebook in at least one department. Biopharmaceutical organizations continue to lead in both the installed base and demand, with over 33 percent indicating at least one installation. Current demand is coming primarily from larger organizations, or those with greater than five hundred employees. Year over year growth is still above 20 percent, making ELN one of the fastest growing informatics technologies.

By work area, drug discovery research continues to dominate the number of ELN installs, predominantly for synthetic chemistry reaction planning and experimental documentation. However, this segment is highly penetrated; stronger growth over the next few years will come from other domains, such as biology which offers a greener field of opportunities. Drug metabolism, pharmacology and pharmacokinetics departments indicate very strong interest to automate manual spreadsheet processes. The largest potential area of expansion for ELN is in analytical chemistry, which naturally spans R&D, quality and service laboratories.

QA/QC, the area of greatest LIMS use, lags R&D with around 10 percent leveraging ELN. For quality applications, an ELN is less of a free-form tool to document an experiment than it is in research. The system is used for documenting the execution of an established method or procedure. However, the interest in QA/QC is very strong — look for the number of installations to double over the next three years.

The non-profit segment of the market, i.e., government and academic institutions, is the slowest to adopt ELN with an estimated five percent penetration. This segment also has the least amount of interest in exploring how to use the technology; a large percentage indicates that “paper notebooks are fine by me.” One reason for the lack of interest could be awareness: 48 percent of those in non-profits indicate they know “little” to “nothing” about ELN. Another third report they “never even heard of ELN” versus just five percent of those in the biopharmaceutical sector. With the very strong growth of ELN in the corporate environment, academic institutions should review if they are properly preparing potential graduates in the tools of the future.

Perspectives of ELN users
There are over 30 suppliers of ELN technology, but the top five suppliers have approximately 60 percent of the installed base of systems. Products are developed by instrument

Half of all ELN implementations are now electronic 
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Figure 2: Half of all ELN implementations are now fully electronic
companies with over $1B in revenue to small, focused upstarts. Most of the smaller ELN players are still relatively unknown in the market; they have considerable barriers to establish a strong brand, particularly a global one. In the past two years, a few of the smaller firms have been acquired by larger companies with stronger distribution networks. As with any hotly contest market, there also have been dropouts and product discontinuations. This active business development environment is projected to continue for the foreseeable future.

By and large, ELN users are quite pleased with the selection of their system and supplier. Generally, the system meets their requirements and has good overall functionality and workflow features. Product speed and performance continues to be a problem for many, and query capabilities are less than desirable. It is not atypical for prospective users to want an ELN to only replace its paper counterpart. After implementation, however, they desire to make better use of the information that is contained within the system. The document-centric metaphor employed by many of the available products often restricts data level integration, reporting and data mining.

As a whole, users report they have been successful meeting their initial project goals and objectives. The majority report that they achieved their anticipated benefits of data sharing, knowledge capture and reuse, efficiency, and data quality improvements. Versus many other systems deployments that typically run over budget, ELN users indicate the time for system implementation was generally the same or less than they had originally planned. Most organizations started in one department and grew out the system as they gained both experience and demonstrable results. This stepwise deployment assisted in change management and user adoption.

The greatest challenge to implementing an ELN continues to be cultural change. The perception of prospective users is that culture will be the largest project hurdle to overcome. Users agree that this indeed was their chief difficulty during deployment. Both prospects and users concur that “general resistance to change” is the primary reason users resist using a system. However, users report that the level of resistance is actually quite lower than what they originally perceived it would be. Seventy-seven percent of organizations indicate the majority of their users readily used the system as shown in Figure 1.

In the period from 2003 to 2005, concerns about the legal acceptance of electronic records plagued the ELN market, forcing the majority of users to implement a “hybrid” model (a hybrid model is where intellectual property records are printed to paper and physically signed). This has changed considerably, driven by modifications in December 2006 to the U.S. Federal Rules of Civil Procedure allowing legal discovery of electronic records in court cases3. “Electronic only” installations, or those not relying on paper for patent protection, now comprise half of all deployments as illustrated in Figure 2.

In summary, the market for ELN is vibrant and growing at more than 20 percent per year. With over 25 percent of laboratories using some technology variation, ELN has grown beyond the early adopter stage to become a mainstream informatics necessity. Tangible benefits and competitive advantages are being realized by those who have made the investment. However, ELN, LIMS, SDMS, ECM, or any other technology category acronym is not the solution to all data management challenges in the laboratory. Based on the current evolution of the market, each technology has its place. Careful attention must be paid to the definition of your laboratory informatics strategy, process analysis, project planning, and change management to ensure project success.

References
1. Elliott, Michael H; Electronic Laboratory Notebooks: A Foundation for Scientific Knowledge Management Edition III; Atrium Research & Consulting LLC; Wilton, CT USA
2. Elliott, Michael H; 2008 Electronic Laboratory Notebook Survey; Atrium Research & Consulting LLC; Wilton, CT USA
3. Elliott, Michael H; “The Rules have Changed: The Management of Electronic Research Records is More Important than Ever”; Scientific Computing (May, 2007)

Michael Elliott is CEO of Atrium Research & Consulting. He may be reached at editor@ScientificComputing.com.

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