A flexible electronic notebook for life scientists - Getting scientists back to doing science in the lab

By John McCarthy

A shared ELN accelerates the collection, analysis, reporting and communication of experimental results by plugging into the systems that life scientists use every day, unlocking the information those systems contain and making critical knowledge sharable within and across multidisciplinary teams.

“Today’s highly configurable ELNs meet the challenge of providing all types of life scientists with a better way of working that does not disrupt familiar workflows, so that scientists can focus on science”
-John McCarthy

Image. Two-way integration between Thermo Scientific Watson LIMS and an ELN makes it easy to store, annotate, search and view Watson LIMS reports and images in the notebook-facilitating collaboration and eliminating manual transcription errors.

Life sciences R&D can be chaotic. After all, life is inherently complex with practically an infinite number of organisms to study and biomolecular interactions that can be difficult to unravel. Further complicating the biologist's task, life is unpredictable. Cells die. Samples are contaminated. Proteins mysteriously aggregate.

How can biologists bring order to the process of capturing and understanding complex biological systems and processes? Even more important-how can biologists spend less time managing and protecting critical information while at the same time unlocking it and making it accessible to colleagues in other disciplines for more efficient experiment design, execution, analysis and decision making?  

These questions are particularly pertinent for life sciences organizations engaged in selecting and deploying an electronic lab notebook (ELN). Working well for biologists is certainly the nominal requirement for a successful ELN. Beyond this, a notebook also needs to streamline scientific workflows by tapping into the systems biologists use every day. And most importantly, a notebook must unlock the silos of biology information that constrain R&D productivity-fostering improved collaboration and transparency within and across multidisciplinary project teams.

The life sciences lab: Fertile ground for ELNs

The primary directive when implementing an ELN in a biology research environment will always be: "First, do no harm." In pursuing optimal experimental results, biologists frequently modify experimental parameters, introducing different buffers, cycles, temperatures and reagents to name just a few variables. Biologists are continually innovating and evaluating different methodologies to corroborate their results. In this way, biology labs develop over time unique information repositories and methodologies, each painstakingly fine-tuned and validated for a particular application. These diverse, proprietary and often chaotic collections of structured and unstructured information, custom workflows and instrumentation set-ups constitute a critical challenge for biology informatics today. They are the major stumbling blocks where traditional paper notebooks and one-off biology data management "silos" fall short in meeting life scientists' needs. Because they comprise the critical components of each lab's specialized IP and expertise, it is also essential that these proprietary systems not be disrupted during an ELN deployment.

Today's life sciences labs offer fertile ground for ELNs because scientists are under increasing pressure to do more with less sooner-and paper notebooks and ad hoc systems no longer support this. Manually cutting and gluing photos, documents and reports into paper notebooks or transferring information to standalone systems only serve to encumber and slow down today's high-throughput electronic lab environment. Furthermore, these traditional systems end up as document graveyards instead of searchable, shared repositories that drive R&D productivity.

Other key challenges addressed by modern ELNs include

• Ensuring that intellectual property (IP) management processes are consistent and compliant in regulated environments
• Weeding out inefficient processes and inconsistent data
• Helping scientists find information when they need it
• Making it easier to share information in a timely manner

First and foremost, an ELN needs to be flexible enough to serve the many scientific domains engaged in bringing small-molecule drugs or biologicals to market-a process in which biologists from multiple disciplines play pivotal roles. Whether engaged in target identification and validation, cell line development, lead optimization, in vitro/in vivo studies, pharmacokinetics, formulation, process development and validation or yield assessments, biologists need to capture results securely and share them easily with medicinal chemists, analytical chemists, process chemists and formulators. An effective ELN must be adaptable to handle the wide variety of experimental methods and processes employed by scientists in all these areas.

In addition, an ELN needs to plug into the overall lab ecosystem supporting the convergence of instruments, software and scientists in the context of evolving R&D workflows. This means working seamlessly with the hardware and software systems that biologists use every day. These research tools include highly specialized material handling and detection equipment, balances, analytical instrumentation and numerous domain-specific software applications for data manipulation, statistical analysis, data visualization, curve-fitting and modeling. Raising the bar even higher, an ELN also needs to let laboratory staff coordinate work requests, material orders, sample tracking and equipment usage, all without leaving the notebook.

A flexible, configurable ELN for all life scientists

Today's highly configurable ELNs meet the challenge of providing all types of biologists with a better way of working that does not disrupt familiar workflows, so that scientists can focus on science. Biologists can return to science and not waste valuable time functioning as laboratory information managers. With today's ELN, biologists have a single, flexible, easy-to-use tool for designing, executing, analyzing, reporting and (most importantly) sharing information and broader domain knowledge. Modern ELNs support the diverse informatics needs of many scientific disciplines without extensive customization.

Deployable as either on-premise software or as a subscription-based, hosted offering, the latest ELNs optimize workflows, make lab processes more consistent, improve collaboration and enhance productivity through knowledge sharing. Simply put, today's notebooks augment the systems biologists already use, unlocking information and enabling project teams to benefit from the knowledge within and around them. In turn, individual scientists boost their own productivity by learning from the successes (and the mistakes) of their colleagues.

As biology research labs increasingly turn to partnering and outsourcing to boost R&D productivity and reduce costs, the latest ELNs are also emerging as collaboration engines for labs working with contract research organizations (CROs) and other geographically dispersed "virtual teams," because ELNs support

• Workflow coordination across geographic and business boundaries
• Experiment authoring by different scientists
• Data access across the globe and between business networks
• Secure control of read/write access at the experiment level
• Regulated and unregulated lab documentation procedures

Accessing an ELN in a subscription-based, hosted environment further enhances operational agility and support for distributed project teams. Hosted notebooks enable R&D labs to focus on their core competencies by shifting responsibility for the notebook infrastructure to a hosted informatics vendor. Hosted options accelerate notebook deployment, reduce costs and provide an earlier payback for notebook investments. Most importantly, a shared, hosted notebook enables transparency between outsourcing organizations and contracted partners. Rather than merely receiving a spreadsheet full of data from its partner, an outsourcing lab also accesses the protocols, methodologies, sample preparation steps and other experimental data used by its partner. This gives the lab a much broader and deeper view into the overall context of the outsourced project-providing scientific transparency that can lead to understanding and breakthroughs.

Whether deployed as licensed software onsite or accessed as a hosted, online application, the latest ELNs enable biologists to continue "doing their own thing"-but in a more efficient, collaborative and cost-effective manner obtained through

• Tight integration with the systems biologists use every day
• Powerful search optimization techniques
• Improved data mining, data analysis and decision support capabilities

Working with the systems life scientists know

Biologists work with a wide variety of lab instruments including balances, spectrometers, centrifuges, fluorometric imaging plate readers, cell and particle counters, flow cytometry, thermal cyclers for polymerase chain reactions. They also depend on numerous software applications for manipulating and analyzing the data collected by these systems. ELNs accelerate the collection, analysis, reporting and sharing of experimental results by plugging into the hardware and software systems that biologists use daily, unlocking the information contained in the systems and making it sharable within and across project teams.

This is a two-way street. An ELN pushes information out to laboratory equipment and pulls it back into a common digital repository. For example, integration with balances accelerates high-volume sample analysis and animal weight checks during in vivo studies by permitting a biologist to send animal weights directly from a balance in the animal room to a notebook in the lab. Other efficiency boosters include the ability to run daily balance checks from the notebook, retrieve up-to-date calibration information in the context of an experiment and update instrument status on-the-fly.

ELNs further streamline biology workflows by plugging directly into the laboratory's work request and materials management systems. For example, scientists can use a notebook to route formulations to the PK lab or use a notebook to send a chemical library from medicinal chemistry to a panel of kinase assays and follow-up screens. Integrating an ELN with lab operation software further streamlines laboratory processes, eliminates workflow bottlenecks and reduces cycle times.

Putting information to work

From an information management perspective, an ELN is much more than just the document dumping ground for past information. A notebook supports the way biologists work, maintaining the techniques and software upon which they depend and augmenting them where that makes sense. More importantly though, a modern ELN indexes information that biologists capture so that others can search and mine it effectively. For example, data indexing makes it possible to search and extract information from multiple kinase assays while correlating in vivo efficacy studies and earlier toxicology work to accelerate decisions and move research forward quickly. Scientists spend less time looking for and correlating information. They get straight to the more interesting and productive work of data analysis, discovery and decision making. They spend more time doing science.

Approximately 20 percent of laboratory data is structured-captured, stored and retrievable in fixed fields within a database or file. Examples include data stored in a spreadsheet, a relational database or a laboratory information management system (LIMS). The remaining 80 percent of lab information is unstructured-information not stored in a formatted database. This type of unstructured information includes the experimental content and context typically captured in a lab notebook, as well as email messages, reports, project plans, presentations and data captured from laboratory instruments.

With over 130 different LIMS available today, no ELN can integrate with every LIMS out of the box. However, a well designed, extensible ELN supports programmable integration, enabling immediate, real-time electronic access to structured data stored in the LIMS and unstructured data in the ELN. For example, Watson LIMS from Thermo Fisher Scientific is a well accepted and validated system for managing pharmacokinetic studies. Two-way integration between an ELN and Watson LIMS lets researchers handle structured and unstructured data directly within the notebook while also eliminating or reducing manual transcription and data manipulation that can result in costly schedule overruns, process errors and regulatory compliance issues. A typical integrated workflow might involve setting up study parameters in an ELN, transferring the parameters and samples to Watson LIMS, executing the study and analysis in Watson LIMS, and reporting the results back through the ELN to a decision support tool that enables cross-study comparison and analysis.

Protecting IP, fueling collaboration

Biologists are increasingly embracing the ELN as a shared, central hub for the capture, consolidation and dissemination of research information and workflow processes in regulated and unregulated environments. Labs that used to shy away from electronic notebooks because of concerns about workflow flexibility, IP protection and industry acceptance of electronic and digital signatures no longer have concerns in these areas. The latest ELNs satisfy today's regulatory compliance requirements with full support for current Good Practice (GxP) specifications, secure audit trails and 21 CFR 11-compliant electronic and digital signatures.

Whether deployed as an on-premise or hosted application, an ELN improves R&D productivity by driving consistent processes and information capture, streamlining lab operations and reducing cycle times. Most importantly, a notebook secures a lab's critical IP while also unleashing it for collaborative decision making across the many disciplines that work together in today's always dynamic (and occasionally chaotic) life sciences research environment.

John McCarthy is VP Product Management Strategy with Symyx's software business unit. Symyx electronic laboratory notebook, decision support, scientific database and hosted informatics offerings give researchers immediate access to critical workflow applications and information. Symyx powers R&D laboratories with information that generates insight, enhances collaboration and drives productivity.