Knowledge Management and Efficiency Gains

In the face of escalating R&D costs, currently estimated at $800 million U.S. to produce a new drug,1 the life science discovery industry is constantly searching for ways to control expenditure, increase productivity, and meet ever-stricter compliance guidelines imposed by regulatory bodies. One promising strategy for the drug discovery industry is to examine how maximum value can be extracted from a life sciences organization’s primary asset—knowledge. Laboratories are producing ever-increasing volumes of experimental data generated by advanced analytical instruments and automated high-throughput methods of research. Typically, these data are scattered among a number of disparate sources, such as individual scientists’ workstations, isolated in-house databases, spreadsheet applications, and LIMS, making it difficult to locate, access, and search. Distributing information within an organization is also problematic when the relevant data are hard to find. Exploiting this research information to effectively turn it into knowledge is crucial in the competitive environment of creating new drugs.

Electronic laboratory notebooks (ELNs) offer an effective knowledge capture and data management solution for today’s information-rich laboratories. By providing one secure and searchable location for all data associated with an experiment, ELNs turn vast amounts of experimental data into corporate knowledge that supports informed decision-making.

ELNs deliver real productivity gains by enabling researchers to work more efficiently, allowing rapid searching, retrieval, and reporting of experimental data that saves research time and costs.

Knowledge management

Capturing, protecting, and exploiting corporate knowledge

The use of ELNs can help overcome some of the major disadvantages of paper notebooks, especially where experiments involve large volumes of data:

1. Knowledge is more easily accessible and can be searched and shared. The chronological nature of a paper laboratory book does not lend itself to quick and efficient searching—experiments can be split over different pages or even books. Finding the required information from a paper system could involve: a) searching through ten 80-page laboratory books, b) visiting a laboratory book central repository, c) signing out one or several specific laboratory books, d) a slow manual search of the books, e) photocopying the relevant pages, and f) returning the books to the central repository.

Systems such as microfiche are used to speed this process, but the benefits in terms of rapid access are minimal. Some laboratories very carefully index the experiments conducted in a custom database, but the information contained relates to project, experiment number, and title. Therefore, to stand any chance of finding the required data, at least two of the variables must be remembered. While paper notebooks do store data in one location, interpretation of these data can be limited; thus the valuable knowledge of the context of experimental data is lost. Access is also limited to the individual and not the organizational level.

Significantly faster data analysis and retrieval using an ELN can free up an organization’s resources to extend its research and discovery beyond the limits imposed by paper-based notebooks. ELNs provide a massive resource for scientists that enables not only instant access to their own current and previous data, but also any other relevant information within an organization, depending on access privileges. With access to extensive search functions that include simple keyword, metadata, or chemical structure searches, the ELN user can scan vast amounts of data and rapidly locate required information. Because all of the knowledge associated with an experiment is stored securely in a central location, ELNs retain the context of an experiment, ensuring that vital associated information is not lost. Bridging the gap between researchers and managers, ELNs effectively translate data into organizational knowledge that supports decision-making and business analysis tasks such as predictive studies, risk assessment, and generation of patent applications.

2. Finding information without prior knowledge of its location. The author of an experiment may be able to locate required information in a paper notebook. However, once the scientist leaves an organization, the knowledge of notebook contents is invariably lost. With a typical drug discovery process spanning many years, the likelihood of experimental history becoming institutional knowledge is severely reduced when only one individual can effectively search the information.

3. Protecting intellectual property. Relying on information stored in a paper notebook presents an unnecessary security risk when a notebook or any of its pages can be lost, stolen, or easily damaged. ELNs prevent misplacement or corruption of data because all experimental data are stored in a secure, centralized database with permission-based access through secure password-protected accounts.

4. Standardizing data capture and analysis. Paper notebooks offer limited scope for providing a means to standardize data capture and analysis. ELNs offer a method to generate standard forms or templates that provide users with a simple way to capture data in such a way as to enable their context to be fully understood and directly comparable with other, similar experiments. The use of forms and templates saves time by simplifying data entry and providing standard formats, controls, and calculations, and in turn enabling true results comparison.

5. Identifying multiple authors. Paper notebooks present limited ways to differentiate one author’s entries from another, for example, with researchers having to record their identity and initials or acronym in a reserved section of the book, and applying the initials or acronym to each notebook entry they make. A manager may also have to check that all researchers have correctly recorded and signed their entries in the notebook and in auxiliary data files. Use of an ELN eliminates these time-consuming methods of author identification.

Efficiency gains

Increasing efficiency and productivity with ELNs

ELNs offer a number of advantages over paper notebooks that allow the researcher to work more rapidly and efficiently.

1. Ease of use. ELNs overcome a number of challenges posed by paper laboratory notebooks by making day-to-day research tasks easier to perform:

  • ELNs allow researchers to import data from any source including directly from laboratory instrumentation. This negates the need to attach printouts to a paper notebook in a location that may be several pages away from related information.
  • ELNs that give scientists a common view of data across disparate research areas enable complete visibility of experimental information, including instrument data, LIMS content, statistical analysis, graphical data, and observations. A well-designed ELN that uses a simple interface permits scientists to adjust to using an electronic system more quickly. Flexible electronic experiment design, for example, can ensure that results entry sheets accommodate all experimental results, reagents, controls, and conditions, with the ability to change parameters during the course of an experiment if necessary.
  • Data analysis is performed more quickly and with greater accuracy due to automated calculation processes and automatic error checking. In addition, typed content reduces problems associated with illegible handwriting, while data acquisition directly from instruments reduces the risk of typographical errors.
  • ELNs dramatically reduce the time needed to gather data for an audit, FDA query, or inspection due to full audit trail and e-signature capabilities. Regulatory compliance can be easily demonstrated via audit trail logging and sign-offs that display each entry and modification made to data, the name of the user performing the action, and time-stamped electronic authentication.

2. Simplifying report creation. The significant amount of time that scientists spend on writing and administering reports from paper-based experimental results could be used more efficiently to conduct research. Writing a report, for example, often involves copying from a paper laboratory book into a spreadsheet or reporting application, duplicating the task of data entry. ELNs can reduce the administrative burden of creating reports, such as reentering, copying, pasting, and formatting report content, decreasing transcription errors and freeing scientists to spend more time on research. The ease of locating and extracting the exact data that researchers or managers want, when they want them, simplifies report creation and improves communication across an organization, ensuring that decisions are based on accurate and current data.

3. Reducing duplication of failures. Repetition of failed experiments is common in the laboratory, and reducing duplication enables scientists to work more efficiently, accelerating project progress and reducing unnecessary reagent consumption. Rapid access to data through an ELN enables scientists to plan the most appropriate experiments based on past data, avoiding costly repetition of previously performed failed experiments. By tracking and easily accessing information from experimental failures, as well as the successes, an ELN allows an organization to learn and benefit from previous experience. For example, by checking whether an assay or reagent worked previously, scientists can amend current experimental hypotheses to reduce unnecessary research time and effort.

4. Managing project work flow. Managing work flow can be extremely time-consuming in a paper system. ELNs, however, provide work flow management capabilities that can dramatically increase productivity as project tasks are completed more efficiently. This is especially true with work that is carried out at different sites/laboratories in different time zones. Automated work flow can ensure that all data and tasks are tracked, and up-to-date views of the project status are available.

By defining a task flow that incorporates the tasks to be completed for each stage of an experiment, and those responsible for completion, an ELN allows a smooth transition through experiment stages. Instant notification of tasks that need to be performed, reviewed, and completed reduces delays in the work flow and removes the need for chasing team members for written signatures. Built-in escalation procedures permit the task flow to progress if an individual is unable to complete a task within the specified time frame.

Return-on-investment (ROI) of an ELN

It is currently estimated that a researcher spends between 5% and 25% of available research time formatting, cutting and pasting, and transcribing data into paper notebooks,2 depending on the level of regulation in a laboratory.

Table 1    -    E-WorkBook time and dollar savings

Demonstrating the payback time for an ELN, this example is based on figures originating from a study of E-WorkBook (ID Business Solutions Ltd. [IDBS], Guildford, Surrey, U.K.) users showing that tasks took 40% less time when using E-WorkBook. Assuming that on average scientists spend 20% of their time using a paper notebook in an 1800-hr work year at an annual salary of $100,000, the example indicates that an organization would save $8000, or 8% of a scientist’s annual salary, by adopting an ELN system over a paper notebook (see Table 1). 

Subtracting the cost of licensing and maintaining an E-WorkBook, at $3000 per scientist for the first year, including maintenance, a company would save well over $5000 per user within just a few months of deploying E-WorkBook. In fact, an organization would see a return-on-investment in the ELN in just over seven months. These financial and productivity benefits are in addition to the qualitative benefits of real-time collaboration, stronger security measures and regulatory compliance, and improved intellectual property protection.

Summary

The E-WorkBook enables organizations to drive the research process with improved efficiency and enhanced security. By offering the ability to share, search, and query experimental data in real time; control access; and issue task requests to other team members, E-WorkBook provides an organization with secure knowledge management that can be accessed and shared with ease. Reducing administrative tasks with significantly faster data searching and retrieval and rapid report generation, E-WorkBook gives scientists more time for research and discovery, boosting productivity and saving costs.

Bringing together every aspect of an experiment, E-WorkBook gives scientists a common view of data across disparate research areas, enabling complete visibility of experimental information. With the ability to personalize to suit individual needs, E-WorkBook mirrors a scientist’s work flow and research activities regardless of area of expertise. In addition to offering the fundamental capabilities of a paper-replacement ELN, the E-WorkBook is an intuitive data management tool for all disciplines that fully retains the context of an experiment, both present and past.

E-WorkBook delivers the right functionality to the right scientists, from synthetic chemists, analytical chemists, and molecular biologists working in early research to pharmacologists working in late-stage discovery and preclinical research. Using a generic, science-neutral approach, E-WorkBook fulfills each researcher’s requirements of an ELN in one application, minimizing IT support and protecting corporate knowledge in a fully compliant environment.

References

  1. DiMasi, J.A.; Hansen, R.W.; Grabowski, H.G. The price of innovation: new estimates of drug development costs. J. Health Econ.  2003, 22, 151–85.
  2. Lysakowski, R. Comparing paper and electronic laboratory notebooks—part 2. Sci. Comp. Automat. May 1997.

The authors are with ID Business Solutions Ltd., 2 Occam Ct., Surrey Research Park, Guildford, Surrey GU2 7QB, U.K.; tel.: +44 1483 595000; fax: +44 1483 595001; e-mail: [email protected].

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