Need for Integrated and Cloud Based Data Management Solutions in Clinical Research
Amit Chopra
Managing Director and
VPGM India and Middle East
Thermo Fisher Scientific

Clinical research, trial management, and implementation can be costly, complex and timeintensive. Traditionally, clinical trials data and documentation have been kept as paper records, which compromises security and is inefficient. Digitizing clinical processes mitigates these issues. This article examines potential of cloud based data management for streamlining clinical development processes, accelerating timelines, and cutting information technology (IT) costs.

There has always been a need for lab information management software (LIMS) in clinical labs, and, until recently, it was common for many different types of software systems to be purchased separately and then customized for the lab's 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 findings could lead to other discoveries across multiple related disciplines. In labs where this was a common practice, this often led to conflicts in priorities, as scientists could not focus on doing research but instead were forced to manage lab infrastructure issues and complex software integration problems that required large amounts of data crucial to drawing conclusion from their research.

It has become imperative for clinical labs to efficiently manage huge amount of data generated by using new technology platforms that offer accurate and reliable lab data management system and allow that allow seamless integration with instrumentation.

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 driven processes away from paperbased methods towards LIMS, which securely captures, stores and archives 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 more time on science and less time entering data or collating results.

Increased Demand for Clinical Testing Drives Need for Integrated and Cloud-Based Data Management Solutions

With an increased focus on precision medicine, 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, and this can help deliver information that may lead to the next companion diagnostic test or therapy in the future. 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 21CFR 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 systems that deliver rapid analysis and results.

With the advent of cloud computing, newer informatics solution models have emerged. With the cloud model, clinical labs are able to purchase informatics solutions that can scale up and down depending on their business needs, rather than committing valuable capital resources to an on premise installed LIMS solution, which will also require a commitment to service and support contracts. This cloud-based model frees the labs from investing heavily in IT (and the personnel required to support this IT-based environment) and allows labs to focus more on the clinical science.

The Unique Data Management Requirements for Clinical Labs

Companies today offer various services models such as Platform-as-a-service (PaaS), Software-as-a-service (SaaS) and infrastructure-as-a-service (IaaS). Each of these models addresses different requirements. With any of these options, the clinical lab can benefit from a data management solution that has no infrastructure footprint. With this type of cloud-based solution in place, clinical labs are better able to focus on their core activities, where clinical workflows can be rapidly mapped, instrument interfaces are instantly made available from a library and lab resources are utilized more productively. Companies offering clinical data management solutions in the cloud provide the option to choose the best practices in the industry, in standard offerings, allowing users to more easily meet the global standards.

Of the three popular services, PaaS can be more easily adopted in the clinical lab domain since the clinical workflow is typically an ensemble of multiple workflows. Each workflow requirement could be met by a specific app , and, in turn, these apps could be seamlessly integrated to build a holistic solution. For example, accessioning the samples could be one distinct workflow, while sample registration and testing could be another workflow. Instrument interface to auto analyzers, NGS, RT PCR etc. require different techniques for data acquisition and processing, which represents yet another distinct workflow requirement, while validation and audit management is another configuration-based workflow. All of these or a selected group of them could be integrated at specific touch points to offer a clinical workflow solution defined by each clinical lab as it suits their unique business requirements.

Thermo Fisher Scientific delivers on cloud-based informatics for clinical labs:

Thermo Fisher's™ Platform for Science is a flexible, extensible, cloud-based platform that helps labs easily collect, store, access, share, and use their scientific data. It is a validated cloud environment, ensuring users that their operations and data integrity requirements are meeting GCP and other quality and regulatory requirements. The Platform for Science clinical solution has apps that map the entire clinical operation from study creation and management to generation of study reports. Depending on the lab's requirement, public (shared) cloud, enterprise (private) cloud or other validated cloud platforms are available from Thermo Fisher Platform for Science.

Thermo Fisher's Platform for Science Software helps scientists 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 real-time from any device. Platform for Science users can create an integrated environment by configuring applications to meet their unique requirements. In a research environment, flexibility in configuring applications to meet continuously changing workflow needs is as important as meeting the increasing demand for more collaboration.

Thermo Fisher's Core LIMS software enables scientific data collection as well as the sharing, analyzing and archiving of the 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 products on the platform. This includes the electronic lab notebook (ELN), scientific data management system (SDMS) and Core Connect, a suite of software integration services designed to make data in the Platform for Science available to be analyzed, used, and shared. The Core LIMS software increases the efficiency of scientific processes by enabling users to manage data in a secure, 100 percent web- and cloud-based environment.