The Efficient Electronic Lab Notebook, One Important Step Further

In drug development one thing is certain, voluminous amounts of data will be recorded. How can we make this data management process fit a more agile approach?

Every year, around US$200 billion is spent globally on health research. Traditionally, the data collected from research and development has been recorded using the low-tech tools of pen and paper. But as research becomes predominantly digitalized, it has become clear that paper laboratory journals and notebooks are no longer the most efficient way to keep research records. Experimental data analysis often relies on digital tools and there is a growing need in many labs to implement an easy-to-use lab management system .

So not surprisingly, many laboratories both within the commercial and academic sectors have resorted to an Electronic Lab Notebook (ELN). The earliest iterations of an ELN date back decades but it is only recently that more advanced ELNs have become integrated into commercial and more specifically contract research companies.

This includes Charles River, which is in the process of incorporating an ELN into its Laboratory Sciences disciplines—specifically in such areas as bioanalysis, analytical chemistry, immunochemistry, and immunology.

Laboratory Sciences studies are important elements in the determination of safety profiles in drug development. Whether it is the analysis of dose formulation concentration in analytical chemistry studies, determination of blood drug levels for bioanalysis work and dosing regimens or establishing the immunological profile of a large molecule or protein, laboratory sciences end points play a large role in Safety Assessment of drug candidates.

An ELN is pretty much as its name suggests. It’s a sophisticated computer program that replaces paper lab notebooks and interfaces with current software and equipment. For our Lab Sciences team, it is allowing them to seamlessly connect chemical and reagent management, front-to-end study design, and table and report generation.

With the ELN, we can increase the quality of our data by reducing paper notebook-related deviations, decreasing study timelines, and reducing QC and QA time through auditing by exception. Users will no longer need to document on paper; everything will be captured in the ELN. This means it will take less time to complete related tasks, including QC and QA.

Delivering a high-quality ELN through GLP validation

All this is obviously exciting, but we are also taking our data management process one step further and ensuring the ELN is also GLP-validated.

In this pilot project, the Lab Sciences team is using an agile methodology to drive the configuration and development of an initial minimum viable product (MVP) that encompasses inventory and one small molecule bioanalysis method. The team will iteratively configure and release modules and added functionality for remaining scientific disciplines. Compliance and quality must not be excluded from an Agile methodology and performing a fully documented Computer System Validation that meets all regulatory expectations and industry standards was an important deliverable for this project.

What we are doing is tailoring the usually cumbersome, time-consuming process of computer system validation into the Agile framework, breaking that validation process up into multiple, more manageable components to deliver faster validated/compliant MVPs. The visual thinking diagram, mind mapping, is one of the tools the computer validation team is using to accelerate and maintain our quality standards for software testing, and to ultimately help take one year off the drug development timeline.

The use of the mind map has several advantages, including:

• Reducing test script time
• Avoiding the need to write individual actions in step procedures
• Enhancing productivity (you get results faster!)
• Reusability – you can build a library of common functions such as login security, audit trail)
• Providing more flexibility and creativity, which then brings higher quality test.
• Opening more opportunities for brainstorming

By employing an agile approach to validation for our ELN, we will launch our MVP in 2022, after only several months of development and validation instead of potentially years of work. We will continue to add modules for other Laboratory Sciences disciplines for implementation periodically by the end of 2023.

And there is much more room to grow in our use of standards and automation for computer system validation. We intend to continue to explore all possibilities and technologies to make this regulated process even more efficient.

How fast and efficiently we work matters to sponsors. They want to move effective and safe drugs to market faster and identify ineffective and unsafe drugs sooner. That is our goal, too, and technology has a real role to play. The GLP-validated ELN is one way of providing a faster return for clients.

Pamela Shaver Walker is currently the CVP, Global Head of Operations at Charles River Laboratories, Safety Assessment. She began her career in toxicology as a research scientist and study director. Over her more than 25 years in the drug development industry, Pam has also held roles including Scientific Training lead, Global Reporting Director, Operational Excellence Executive Director, Corporate Vice President Data and Report Delivery Services. Pam is passionate about reducing drug development timelines through operational excellence, process optimization and digitalization. As part of her “day job”, Pam partners with senior leaders to drive initiatives that converge across operations, such as capacity management, scheduling, technology and learning and development program evolution.

This is the second in a monthly series of blog articles about how technology can help pick up the pace of drug development. Check out our earlier story about a nifty digital cell donor recruitment tool.