The Growing Need for Data Management Solutions in Clinical Labs

An Interview with Nicole Rose, Senior Application Manager

Thermo Fisher Scientific

Would you say demand for LIMS in clinical labs growing?

There has always been a need for lab information management software in clinical labs, up until recently it was common for many different types of software systems to be purchased separately and then customized for the lab’s particular needs. This commonly involved lab IT involvement or in many cases, skilled scientists managing software implementation and customization.  Key among the needs of these labs was not only data management within the lab, but also sharing that data with colleagues and other collaborators across diverse industry environments so that acceleration in findings could further discovery for multiple related disciplines. In labs where this was common practice, this often led to conflict in priorities as scientists were pulled from the discovery process to manage lab infrastructure issues and to manage complex software integration problems that could allow for large amounts of data to be managed and shared.  But the explosion of data generated now by the rapid pace of discovery in NGS, omics and clinical labs requires that lab data management technology allow for seamless integration with instrumentation and analysis of enormous amounts of data from multiple sources, enable the sharing of that data with numerous remote collaborative teams and free up scientists to focus on their science, and not on software management.  

With advancements in technology such as sequencing, microarray and qPCR, sample throughput has increased in these labs. Likewise the drive towards precision medicine has accelerated the demand for these technologies.  This combined with CLIA/CAP requirements for clinical labs has drive processes away from paper based and towards LIMS, which securely capture, store and archive sample data as well as any permissions or training records related to the expertise of the staff executing specific test protocols. Along with the need to automate more of the lab to manage the increase in throughput, a LIMS becomes a critical tool enabling scientists to focus on science and less time entering data or collating results.

The increasing demand for innovation in research and the related pressures to deliver on the most promising findings from discovery are also driving the need for simultaneous innovation in the technologies that enable that innovation and, likewise, the reliance on data management solutions that respond to an increasingly complex scientific environment.

What is driving this demand?

With an increased focus on precision medicine and advancements in genomic technologies, there has been an increase in the numbers of clinical labs, a sign that the demand for their testing services is requiring more capacity. Because of CLIA/CAP and HIPAA requirements, these new labs are opting for LIMS solutions for data management as opposed to paper based solutions.  Given the high volume of data, there is also a need for more automation in these labs, and having software that integrates with the lab instrumentation, bench and enterprise systems is critically important.  By integrating the lab and making the LIMS the central repository of sample data, workflow and reporting, scientists can spend more time working on processing the demand and not entering data.

Also, as physicians are seeking the most targeted therapies for their patients, researchers are focused on collating the most comprehensive set of options that can lead to treatment and cure of the most devastating and costly of health issues. Personalized medicine requires that labs deliver results rapidly and in full compliance with patient data safety requirements. If the end goal is for a physician to have a complete data set following a patient from point of care to molecular testing diagnosis and treatment, then that requires an informatics solution that delivers immediate access to data with no artificial barriers related to the sources of that data. And with the discovery occurring across all phases of life sciences research, all participants, from the research community to pharmaceutical and drug manufacturers to the physicians, are all at some point requiring access to the learnings that are being revealed across this broad constituency of data users.

For example, for cancer research, informatics solutions have been developed to manage, and ultimately interpret, the significant quantities of variant data produced by next-generation sequencing (NGS), which presents a formidable challenge. In oncology specifically, the wide range of variants in tumor and blood samples presents challenges for efficient, accurate, and thorough analysis of cancer-relevant data.

What are the unique informatics management requirements for clinical labs? 

In addition to the regulatory requirements related to accuracy and reliability of test results (such as CLIA/CAP) as well as patient privacy concerns regulated by HIPPA, and FDA guidance (FDA 21CRA part 11), clinical labs are tasked with increasingly time and patient sensitive test regimes and require not only highly specialized and accurate instrumentation, but also data management solutions that deliver rapid results and analysis. For example, targeted next-generation sequencing is empowering laboratories of all sizes to confidently pioneer breakthroughs in cancer research. At the core of these breakthroughs are assays and panels designed to achieve highly sensitive results from minimal sample input – to help deliver information that may lead to the net companion diagnostic test or therapy.

How do your LIMS address these needs?

Thermo Fisher Platform for Science software provides the scientific community with a flexible, scalable and secure way to collect, store, analyze and share information. Scientists can perform the most simple or complex tasks, from tracking sample inventory to automating data collection for High Throughput Screening and physicochemical profiling, all while collaborating in real-time from any device. Platform for Science users can create integrated environments by configuring applications to meet their unique requirements. In a research environment, flexibility in configuring applications to meet continuously changing workflow needs within the lab as customers add new test types, is as important as meeting the increasing demand for more collaboration. A LIMS that can evolve with these challenges is essential to keeping pace with and increasing the rate of discovery.

The Thermo Fisher Core LIMS Software enables scientific data collection, as well as the sharing, analyzing and archiving of scientific data. The Core LIMS software can automate workflows, and manage samples and data. Pre-built workflows can be quickly configured to meet the exact specifications of your lab. The information in the LIMS can be easily reported on, shared, analyzed, and audited. For researchers in clinical labs, Core LIMS software gives companies a strategic advantage by enabling them to efficiently collect and analyze data.

The Core LIMS software runs on the Platform for Science and integrates seamlessly with instruments and software from an organization’s preferred vendors while sharing information with other applications on the platform, such as the ELN, SDMS, and Core Connect. The Core LIMS software increases the efficiency of scientific processes by enabling users to manage data in a secure, 100% web- and cloud-based environment.

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