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The New Digital Age of the Laboratory Considerations for Better Data Provenance

The lab environment of today is moving towards a more data-intensive science. At the same time, however, many labs are still operating with documentation methods of the last century. The progress enabled by new computing power, lab software, and analytics processing often resides within a flawed documentation system where lab techs peer at device readings and take handwritten notes. Those notes are transcribed into Excel, and sample tracking, preparation, data analysis, and reporting are done in silos.

Digital transformation of the laboratory necessitates the digitizing processes and improving accessibility to data across the lab. However, science professionals with sophisticated lab tools and some of the most powerful computers in the world continue to work out of notebooks and manually copy data from one system to another, often using paper as the intermediary. The process may feel like second nature, but the potential for transcription and transposition errors increases every time data is manually moved from one source to another. Double data entry may help catch many of these errors, but the time associated with these kinds of redundant activities can be costly.

Truly modernized labs are moving away from processes that exist in silos. Labs are beginning to unify sample, experiment, and protocol management with the goal of making sure that all steps of their process are documented digitally and accessible. Labs can better track and manage all data under a single umbrella. When these processes are unified, workflows are streamlined, compliance standards are more easily met, and provenance is strengthened. A technology solution alone doesn’t equate to a modern system with strong provenance. More than the system, a strong provenance is established by evaluating all processes from the ground up so that there is a cohesive understanding of what everyone in the lab is doing. Lab modernization means establishing a holistic approach to your laboratory science.

The Case for the Holistic Approach

Provenance should begin the moment a sample enters the lab and continue to be tracked until the final results are published. The holistic approach to the lab data experience is a step towards both lab modernization and better science. World-class labs are adopting a holistic approach. By ending functional lab silos, they are creating efficiencies in reporting that allow them to better track, manage, and document all steps of the lab process. World-class labs are not only breaking down the process silos, but they are also streamlining the data flows within and between these silos, thereby creating a foundation for strong provenance.

We are living in an age of amazing innovation. Technologies like next-generation sequencing, mass spectrometry, and functional MRI are allowing revolutionary scientific advances. These enabling technologies bring a new challenge, with considerations needing to be made on how to handle the greater data loads that arise from these new technologies. Taking a holistic approach to these big data loads means that the tools and software handling this data must be tied together. Although working with thousands of lines of data in Excel might be achievable without a management system, this is not possible with a larger data set. Bigger data means that there’s more room for failure. The big data age not only demands a holistic approach for unified lab processes and reporting, but it also requires a management system that can meet the specific needs of the modern lab. By adopting a holistic approach, one where processes are unified and lab provenance is strong, labs can start to achieve a greater science. So how do labs choose a management system that brings them closer to this ideal?

Modern Labs Must Employ Modern Management Systems

Out-of-the-box data management tools have limitations that don’t meet the integration needs that are required of the disparate and often disjointed scientific software and hardware toolkit. Many tools only support one aspect of the workflow, blindly passing data over the fence into the next silo. Your modern management system should be modeled based upon how a modern lab works. Wet lab tasks, analytical tasks, and reporting tasks are all part of the process now. Digitally transforming your laboratory workflow requires more than understanding the technology from an IT perspective. It means using one’s understanding of the science and the technology to create an integrated approach.

An improved scientific process can be achieved through a management system that recognizes and employs a holistic approach. This means solving the challenges of lab managers who need greater insight, IT staff who needs to manage multiple systems, and end users who need specific reports. A fully modernized lab employs an end-to-end platform that prioritizes a streamlined workflow, has the ability to comply with any standards, and has strong data provenance. A more complete and sound science can be achieved when data collection, processing, analysis, and reporting is managed by a single system. This not only streamlines and better organizes your current process, but it also allows your data to be queried years after laboratory studies are complete.

The New Digital Age of the Laboratory – Building Better Science Solutions

In today’s digitally transformed laboratory, you need a flexible informatics solution that integrates easily with your existing systems and is designed to support the way you already work. This means the ability to configure it to support your current processes, practices, and regulations. Your modern informatics strategy may also need to accommodate legacy or siloed technologies as part of an interim or longer term approach.  Unified platforms with common modules are the easiest path towards achieving a digitally connected enterprise with the needed flexibility to support a wide array of informatics requirements.

L7 Informatics, recently named by Gartner as one of the “Cool Vendors in Life Sciences that technical leaders should watch”, provides a revolutionary workflow management software platform for companies using data-intensive scientific techniques. The L7|ESP Science Platform is a fully-integrated, comprehensive hardware and software solution that is customizable to your specific laboratory requirements. The L7|ESP platform can also be deployed as an overlay system on top of existing siloed systems to tie them together and minimize legacy disruption or if needed, replace existing legacy systems, providing a big-picture view of the entire laboratory workflow.

Success in laboratory informatics projects can be difficult to achieve largely due to the complex processes and technologies utilized in laboratories, and the many different aspects of the workflow across the enterprise. At Astrix, we believe that if you are going to invest the time and resources into a digital transformation initiative, it is important to ensure success by applying a proven methodology. Our focus is on solving the challenges experienced by scientific organizations through a Value Engineering approach. The Astrix Approach is a comprehensive, methodical and flexible framework which is designed to ensure your laboratory informatics project is a success and maximizes business value for your organization.

Why it Matters for You

In the new digital age, the modern laboratory is focused upon eliminating data silos, allowing them to create efficiencies and streamline the flow of large amounts of data across all steps of the laboratory process.  This holistic approach creates the foundation for strong data provenance and better science. Employing the principles below will lay the foundation for the achievement of operational excellence within your organization.

• Evaluating all of your processes from the ground up will provide a cohesive understanding of all laboratory functions, allowing you to fully streamline, optimize and leverage all aspects of your workflow.
• Digitally transforming your laboratory operations will eliminate manual processes, thereby allowing for strong data provenance leading to better science.
• Integrating your workflow utilizing an end-to-end platform will enable you to automate your operations and gain total visibility over your entire laboratory operations leading to sustainable improvement and scientific innovation.
• Selecting an informatics technology with an underlying architecture that provides deep data provenance, robust monitoring capabilities with built in security structures is best positioned for achieving regulatory compliance standards.

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Precision medicine is revolutionizing the way we approach modern healthcare by offering medical treatment customized for an individual patient. Medical decisions can now be tailored, or ‘personalized’ to an individual based upon predictions relating to therapeutic responses or risk of disease. Molecular diagnostics enables this novel approach to healthcare through the analysis of an individual’s genetic code and resulting protein expression profile. This rapidly advancing field allows for the determination of a person’s risk for certain diseases through the detection of biomarkers. Molecular diagnostic tests also serve to better inform the selection of targeted therapies and to subsequently monitor the effectiveness of the treatment based upon the resulting changes in the biomarkers.

Until now, informatics solutions required to effectively support the accelerated advancement of precision medicine were not commercially available. With the introduction of the L7|ESP Enterprise Science Platform from L7 Informatics, diagnostic organizations are able to use a single platform for complete end-to-end assay automation and complex data management across the entire workflow. L7|ESP digitizes data, automates processes, and manages the patient precision medicine journey across various silos such as patient consent management, specimen collection, sample preparation, wet lab processing, NGS sequencing, and advanced informatics (including bio-informatics/AI & ML), diagnostic decision support, outcomes tracking, disease registries, and clinical trial management.

In a recent interview with Dr. Erica Tennenhouse, managing editor of Clinical Lab Manager¹, Dr. Vasu Rangadass, President and CEO of L7 Informatics,  shares his vision on how the L7|ESP integrated data management platform can support diagnostic laboratories by breaking down data silos to achieve operational excellence.

Q: What are the greatest informatics challenges that diagnostic labs face today?

A: I think the number one problem that we see is data silos. Typically, the more advanced diagnostic labs have their own home-grown system because they didn’t see any viable solution in the market. As genomics medicine becomes standard of care, especially in the treatment of cancer and rare diseases, we see molecular diagnostics growing rapidly. You want fast turnaround times and accurate audit trails and full data provenance. All of that is not easy to do when you have siloed systems and paper intermixed with Excel spreadsheets.

Q: How is L7’s Enterprise Science  Platform solving these challenges?

A: Traditionally, people use LIMS systems to manage the wet labs and then they use bioinformatics pipelines to manage the informatics analytical pipelines. L7 was created to break down this wall and create one integrated platform. We’ve now expanded our scope beyond breaking down this one wall between wet lab and dry lab to breaking down walls between sample management, sample accessioning, sample inventory management, reagent inventory management, and freezer or location management. We’ve incorporated all of this into one integrated platform called ESP. It’s kind of like an operating system for the lab with different applications, so it’s a much more modern architecture to support the lab of the future where people don’t have to buy multiple different systems. We created one platform and LIMS just happens to be one app and there’s also an inventory management app and a location management app. Customers can pick and choose what apps they want, but all of the data in the lab, both scientific data and operational data, is in one place. We can support digitization, workflow automation, and all of these other functions because we are a single platform to support all the lab needs.

Q: What prevents all labs from adopting an integrated data management system?

A: I think the main bottleneck is that customers already have an existing system. But even customers with existing systems are looking to use ESP as an overlay system on top of their siloed systems to tie all of their siloed systems together. ESP can replace existing legacy systems or overlay on top of those systems and give them a big-picture view of the entire lab. We have customers that are using it in both modes.

Q: What types of diagnostic labs stand to benefit most from your platform?

A: Molecular diagnostics labs—so people doing qPCR for COVID testing or whole genome sequencing for rare diseases or RNA sequencing for cancer or exome sequencing. It’s really all the molecular diagnostics that we are focused on because they are the ones that have the most complexity. But that doesn’t mean that our system is only useful for molecular diagnostic companies; I think we can support any diagnostic. Our system is also fully regulatory compliant, so our customers are using this not only for molecular diagnostics and companion diagnostics but also for manufacturing quality control and manufacturing automation. We have customers both in the precision diagnostics space and also in the cell and gene therapy space using this for doing quality control and manufacturing execution

Conclusion

Precision Medicine is rapidly becoming the new frontier for the future of healthcare. Molecular diagnostic testing is enabling customized approaches to support more effective treatments targeting the personalized needs of individual patients. To help diagnostic testing organizations overcome the challenges brought about by the increasing need to automate workflows, manage large volumes of data, and meet stringent regulatory compliance requirements, the L7|ESP platform provides the innovative tools needed to meet the demanding requirements of today’s diagnostic laboratories.

Why it Matters for You?

Through the elimination of legacy data and process silos, l7|ESP enables the diagnostic laboratory to increase reproducibility and efficiency while decreasing errors and turnaround time to achieve operational excellence.

• Breaks down data silos through integrated data management strategy
• Automates and streamlines all the workflows and data capture across the clinical pathway
• Achieves regulatory compliance requirements: CAP/CLIA/cGMP/CFR part11 and HIPAA
• Integrates with scientific instruments, medical devices, imaging systems, EMR, ERP, lab informatics, and digital pathology systems
• Provides end-to-end tracking of the patient treatment with complete audit and decision support capabilities
• Allows for better collaboration between researchers, physicians, nurses, informaticians by placing them on a single operational platform with full audit capabilities
• Expedites queries about the patient treatment status, by keeping all your data in a cross-referenced single repository
• Provides reliable and easily accessible data documentation to facilitate accurate submissions for regulatory approvals

About Astrix:

Astrix partners with many of the industry leaders in the informatics space to offer state of the art solutions for all of your laboratory informatics needs.  With over 25 years of industry proven experience, Astrix has the informatics specialists and business process analysis tools required to develop and implement the solution that works best for your enterprise. Our domain experts have helped hundreds of companies globally effectively navigate their digital transformation journey, connecting people, processes and systems to accelerate the advancement of science and medicine.

¹E. Tennenhouse, “Breaking Down Data Silos in the Lab”, Oct. 22, 2020, Breaking Down Data Silos in the Lab | Clinical Lab Manager , Clinical Lab Manager, accessed Feb 9, 2021.

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There is a need for a data and process automation platform that allows diagnostics companies to rapidly setup complex assays and automate the entire “diagnostic order” to “report generation” process and collect all the scientific, quality and regulatory data across the process with full data provenance and audit requirements. L7 Informatics’ Enterprise Science Platform (L7|ESP) is a scientific information management (SIM) platform that enables diagnostic organizations to use a single platform for registering and processing samples, running complex analyses, and delivering data to physicians and patients. L7|ESP provides complete end-to-end assay automation and is designed to increase reproducibility and efficiency while decreasing errors and turnaround time.

The Business Challenge

Diagnostics laboratories are faced with many challenges in the effort to digitalize their operations while incorporating advanced technologies such as NGS or AI into their daily workflow:

• Bi-directional integration to various electronic medical records systems in the market
• Lack of real-time visibility to the final report generation so that providers know the expected date of report and plan treatment accordingly
• Complex integrations to new and old instruments across wet lab sequencing and bio-informatics (primary, secondary and tertiary analysis)
• Ability to plan lab resources and manage normal and stat orders on the same system.
• Lack of instrument validation and reagent inventory management that is integrated into the LIMS systems

The L7|ESP Solution

Legacy data and process silos hinder efficiency and science, increasing risk for business and patient.  The L7|ESP platform breaks down data silos through an integrated data management approach that delivers a quantifiable business impact:

• Improved regulatory compliance. L7|ESP is a GLP, GCP and GMP compliant platform
• Increased quality of tests performed due to automated SOPs with a seamless integration between wet lab and computer lab
• Improved efficiency, faster turn-around times and lower cost with more efficient utilization of resources and inventory
• Real-time visibility to “where is the sample?” and the status of the “ where is the report?” to internal account teams as well as ordering providers
• Real time integration to Instruments, CRM systems, Ordering systems and EMR systems
• Verification of inventory and instrument readiness prior to test start
• Automated reordering of reagent inventory
• Integrated freezer and location management

The L7|ESP platform provides diagnostic companies with total visibility over all their operations while digitizing, integrating, and automating the entire precision diagnostic workflow. This streamlined approach will dramatically increase sample throughput and quality assurance in results while providing reliable documentation for regulatory review and compliance (CAP/CLIA/GLP/cGMP).

Why It Matters for You

L7|ESP allows you achieve operational excellence by increasing sample throughput and providing better reproducibility while being a fully integrated and automated process.

• Total digitized visibility across all integrated operations
• Break down data silos through integrated data management
• Elimination of manual processes throughout the entire workflow
• Improved data accessibility to better inform research and business decisions
• Comprehensive validation strategy for improved regulatory compliance
• Increase efficiencies to achieve operational excellence across your organization
• Reduced operational costs and faster time to market

By breaking down data silos with the integrated data management approach of the L7|ESP solutions, next-generation diagnostic companies can provide superior diagnostic service, with reliable and easily accessible data documentation for increased confidence in your results and efficient turnaround time.

About Astrix

To maximize the benefit of implementing transformative technology such as the L7|ESP platform within your organization, working with a proven informatics solutions expert is vital to the success of your project.

Astrix is an industry leader in helping scientific organizations implement and integrate new informatics systems in the laboratory since 1995. Our experienced team of expert informatics consultants bring together technical, strategic, regulatory and content knowledge to provide the most effective solutions to problems faced by scientific organizations.  Astrix partners with many of the industry leaders in the informatics space to offer state of the art solutions for all of your laboratory informatics needs.  Our domain experts have helped hundreds of companies globally effectively navigate their digital transformation journey.

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To digitally transform your operations into the lab of the future, enterprise enablement must occur as part of the digitalization process.  Many laboratories today are made up of siloed technologies both within individual laboratories and throughout the organization, resulting in disparate and redundant systems.  Older systems that are not able to handle advances in technology further hampers system connectivity and laboratory automation initiatives.  These siloed lab data management systems dramatically reduce the overall business velocity and efficiency, increasing the cost and speed at which drugs and products are produced.

Laboratories and their scientific instruments must be integrated into the larger enterprise architecture to support business goals such as speed to market, regulatory compliance and cost of development.  Unified platforms with common modules are the easiest path towards achieving a digitally connected enterprise.  The L7|ESP Enterprise Science Platform breaks down barriers to this effort by providing streamlined processes and better data management across all laboratory functionalities. The L7 solutions integrate with external, in-house and open-source tools to create a seamless workflow.  Operational excellence stems from better use of resources and faster, higher quality results.

L7|ESP is a unique foundational platform for integrating lab operations.  The L7 customized, scalable approach enables rapid scientific advancements by creating enterprise solutions that integrate functionality across the entire workflow to reduce redundancies and vastly improve operational metrics.  L7|ESP software can be deployed on the cloud-hosting provider of your choice or on-premise within your own cloud.  The platform is designed to seamlessly manage data intensive workflows, creating a data architecture roadmap specifically designed for your data strategy and informatics needs. Applications within L7|ESP are discrete software modules with specific functions.  This modularized platform enables you to only use the tools that you need while having the ability to easily add functionality with the changing requirements of your business.

The main bottleneck that prevents most labs from adopting an integrated data management system is that laboratories already have an established array of systems and technology. The L7|ESP platform can be deployed as an overlay system on top of existing siloed systems to tie them together and minimize legacy disruption or if needed, replace existing legacy systems, providing a big-picture view of the entire laboratory workflow.

Why It Matters for You

Through the creation of enterprise-wide solutions that integrate functionality across the entire workflow, L7|ESP reduces redundancies and improves operational metrics:

• Easily integrate and automate workflows
• Foster collaboration and expedite research
• Total visibility over your operations
• Scientific data and processes in one place
• Better data access and higher quality data
• More informed decision-making across the organization
• Improved regulatory compliance
• Significantly increase operational efficiency

Whether developing your digital transformation strategy from the ground up or navigating this initiative within your existing informatics framework, the L7|ESP platform is the unifying solution to enable seamless connectivity across your enterprise for the next phase of your digital journey.  By breaking down the barriers between sample management, sample accessioning, sample inventory management, reagent inventory management, and freezer or location management, the L7|ESP integrated platform serves as an operating system for the lab with different applications.  With all of the scientific and operational data in one place, this comprehensive solution alleviates operational pain points and increases efficiency to achieve operational excellence across your organization.

About Astrix:

Astrix partners with many of the industry leaders in the informatics space to offer state of the art solutions for all of your laboratory informatics needs.  With over 25 years of industry proven experience, Astrix has the informatics specialists and business process analysis tools required to develop and implement the solution that works best for your enterprise. Our domain experts have helped hundreds of companies globally effectively navigate their digital transformation journey, connecting people, processes and systems to accelerate the advancement of scientific discoveries.

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