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Issue 12

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Where our team of guest writers discuss what they think about the current NGP US Issues.

Peter Duncan
Director of Business Development

Can digital pathology save drug development?

Peter Duncan of Definiens discusses the potential of digital pathology.
07 Jul 2010

Electronic Lab Notebooks: improve efficiency by spending less time on paperwork and more time on R&D

Agilent Technologies | www.chem.agilent.com

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Although information searching, collection, publishing and sharing are now almost completely performed electronically, in some situations the collection and capturing of information is done in the traditional way – e.g., lab notebooks. Most scientists still gather their experimental data in the form of handwritten notes and printouts or cut-outs stuck in their notebooks – the vast majority of such data cannot be shared with others. It remains hidden and unused.

Once it became clear that a move from paper-based to electronic lab notebooks was feasible, visionaries in pharmaceutical R&D management recognised the potential benefit of building a knowledge base for all experimental information within their organisations; scientists would have easy access to the work of others and would not need to repeat failed operations. At the same time, pragmatists drew on their experience of IT systems and were naturally wary of imposing another new, complex application on scientists who have better things to do – namely, research.

Real life benefits of Electronic Lab Notebooks

Multi-site, multi-language deployment
In 2002, a leading pharmaceutical company successfully implemented the Kalabie ELN into their industrial affairs process development, initially in synthesis chemistry. Implementation included four different sites in four different languages, with deployment to more sites currently in the pipeline. Since implementation, over 20,000 experiments have been recorded. The Kalabie ELN has saved the company’s researchers significant time and effort by eliminating repetitive tasks such as the documentation of similar experiments (through the cloning function) and the editing of analysis requests. Now that Kalabie ELN deployment is under way to analytical chemists as well, the whole chemist-to-analyst workflow will benefit from even more substantial gains than originally anticipated.

Improved quality of research results
Elsewhere, a major biotechnology company was delighted by the increase in quality of their experimental records. Not only they were readable, they were above all more complete. Many knowledge base systems suffer from the quality of the information entered, so this is a good indicator of ease of use.

Key selection criteria for electronic lab notebooks
To be successful, an electronic lab notebook has to be user friendly, intuitive to use and must adapt to the user’s various workflows. These were key considerations from the start in the development of the Kalabie ELN.

Easy application
Kalabie ELN provides an ‘all day, every day’ application workspace for research scientists – a central repository for ideas and knowledge created from data and experiments. Special attention has been paid to make the application as easy and natural to use as possible.

It’s an environment that can be adapted to dedicated roles and specific workflows, preventing individuals from unnecessary functions and overloaded workspaces. The modern intranet user interface guides the scientist through the data entry process in chronological order. Often-used functions are immediately available; right-click functions add contextual feature access, while specialised screens give access to more advanced functions. As a result, training for end-users lasts no more than a day.

Adapting to user and research activity
Like most computer users, research scientists do not want to adopt additional computing tasks unless they explicitly benefit from them. As a result, products that claim to facilitate the R&D process have to be highly flexible, intuitive and easy to use.

The discovery process is constantly changing and researchers do not want to become database programmers in order to adapt the software structure of their e-notebooks. To more deeply understand researchers’ needs, Kalabie ELN was developed over several years in close cooperation with partners in the pharmaceutical industry. Kalabie ELN can be configured to many areas and domains, and it provides users with an environment that is well adapted to R&D activities.

The generic configuration is very flexible, with rich text, file and image handling features and user administration of experiment templates. To date, it has been used for biology, analytical chemistry and engineering applications. Standard Chemistry configuration) provides predefined environments with specialised areas to assist the chemist with experiment design and planning, as well as results where batch characteristics can be entered ready for registration. These configurations integrate specific chemistry tools and cartridges that the chemist needs and can be adjusted and customized to for specific customer workflows.

Intellectual property protection
The growing need for detailed documentation and protection of intellectual property, as well as the need to meet the strict standards of the US Food and Drug Administration (FDA), is another factor that is driving the industry to embrace electronic notebooks. Kalabie ELN adheres to these requirements; its IP protection is based on electronic signature, long-term data format preservation and 21 CFR Part 11 conformity and audit trails mechanisms.

Open architecture/integration
A key to the success of Kalabie ELN in research organisations both large and small is the open nature of the architecture. Designed to integrate the tools and applications that the customer uses today, it eliminates the need for researchers to learn new tools and avoids inconsistencies between different vendors’ applications. For instance, Kalabie ELN configured for synthesis chemistry works with a choice of chemistry drawing tools, structure checkers, cartridges and enumerators from providers such as Accelrys, Chemaxon and MDL.

Furthermore, standard connectors and web applications provide seamless interfaces with external applications, such as inventories, registration systems and intellectual property systems, accelerating the general throughput of data in the R&D information system and increasing quality by eliminating the need to reenter information.

Solutions for the complete lifecycle of analytical information
Through a series of strategic acquisitions including Scientific Software, Inc., Computational Biology Corporation, Silicon Genetics and Kalabie, Agilent has expanded and strengthened its portfolio of informatics software for the life science and chemical industries. The integration of these software solutions addresses the complete lifecycle of analytical information – from experimental design to data acquisition through knowledge management and analysis. Agilent’s combined software products give researchers and chemists access to an open system architecture that can integrate applications, instruments, and data into a rich source of information and control of their lab – regardless of vendor.


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