Supporting Preclinical Trial Operations with R&D LIMS Configuration

Blog: Supporting Preclinical Trial Operations with R&D LIMS Configuration

Research and development in the pharmaceutical and biotechnology industries is fast paced and getting faster, while the pressure is on to decrease spending and improve time to market. There has been much discussion about increasing efficiency and precision in the preclinical phase to support the overall goal of getting treatments to market faster at a reduced cost. As the research and development sector evolves, so do the requirements for robust systems that can manage large volumes of data, ensure fulfillment of regulatory requirements, and streamline operations. A laboratory information management system (LIMS) is an important tool in fulfilling those requirements. LIMS are highly flexible, but they must be configured to support R&D processes and your specific lab to get the most value from your investment. This blog post will look at some of the ways a LIMS can support your preclinical lab when properly configured.

Advantages of an R&D LIMS for Preclinical Data Management

Large quantities of data are collected during the preclinical phase of research and development. These data include everything from the results of experiments to how samples are tracked. Storing this information in a spreadsheet quickly becomes problematic, due to the issues of version control, access control, and eventual capacity limits. With a LIMS, almost limitless quantities of preclinical information can be stored, viewed, and analyzed. Accessing and managing data through the LIMS ensures that the data are correct and makes it easy for experts to find and share relevant information.

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Improved Regulatory Compliance with R&D LIMS

Preclinical trials are subject to many governmental regulations and industry standards. It’s important and challenging to stay in compliance with these requirements at all times. Many compliance-related processes, such as audit trails, electronic signatures, and data validation, can be automated with some simple LIMS configuration, which helps laboratories ensure that they are in compliance with the applicable standards and regulations.

Simplified R&D Workflow Management

A LIMS can improve the efficiency of lab workflows by automating repeatable processes. Whether these workflow processes involve sample registration, the distribution of tests, or the validation of results, a LIMS can guarantee that procedures are consistent and efficient, lowering the likelihood of errors caused by human intervention. Standardizing workflows with a LIMS can also be an important part of organization-wide risk management plans.

Leveraging Integrations With Other Systems and Instruments

The ability to integrate with other laboratory systems, such as Electronic Lab Notebook (ELN) or Enterprise Resource Planning (ERP) platforms, is a standard feature of many LIMS platforms. Some R&D LIMS are available with integrated ELN out of the box. Implementing system interconnectivity guarantees that data flows easily across platforms, which in turn boosts the overall efficiency of the laboratory.

Instrument integration with LIMS provides significant efficiency gains by moving data straight from the instrument into LIMS without manual intervention. Be aware, however, that in the preclinical lab any instruments or systems that are integrated with the LIMS will also need validation.

Real-time Monitoring and Analytical Functionality with R&D LIMS

Researchers gain the ability to monitor trials in real time using LIMS, which enables them to make fast corrections when abnormalities appear. For samples that need to be stored within a specific temperature range, a LIMS that has been integrated with the temperature sensor can alert lab scientists if there’s a temperature deviation. LIMS will note the event in the sample data, including the time, duration, and location of the temperature fluctuation.

The R&D LIMS can also be integrated with automated dispensing equipment that is often used to give medications to lab animals. LIMS can detect a deviation if a study subject gets a dosage that’s outside the defined range. LIMS will alert involved personnel that a deviation happened and record all relevant data in the trial records. This allows the study supervisor to quickly respond and evaluate the impact, providing an opportunity to administer medication to counteract the effects of the altered dose.

In addition, the built-in analytics tools available with most LIMS can provide insights into trends, performance indicators, and other important data, all of which contribute to better informed decision making.

Better Distribution of the Available Resources

The LIMS gives stakeholders an accurate picture of how resources are being used, whether those resources are equipment, people, or consumables. The trending data available in the R&D LIMS can indicate when additional staff should be present in the lab, or when pipette tips need to be reordered. Forecasting needs, in this way, allow preclinical labs to save money by scheduling correctly, keeping overtime and express shipping costs to a minimum.  The historical data in the LIMS makes it easier for lab managers to keep projects on track and ensure that they don’t go over budget.

Improved Sample Tracking

Tracking samples is a critical part of preclinical research and development. The extensive sample tracking tools provided by LIMS help to ensure that samples are accurately labeled, stored, and used in the most efficient way. Integrating a barcode generator and reader with your LIMS is a great way to improve the sample tracking process. Some examples of the sample tracking possibilities with LIMS include the following:

  • Sample lifecycle management—tracks the entire lifecycle of a sample from receipt to disposal, including any tests done on the sample
  • Chain of custody tracking—a detailed record of everyone who has handled the sample, with timestamps and what they did with the sample while it was in their custody
  • Sample aliquot tracking (genealogy)—tracks subsamples created from the main (parent) sample

Capacity for Scale When It’s Time for Expansion

The requirements for data management in research laboratories continue to grow as labs expand and develop. LIMS platforms are scalable, which ensures that they can handle greater data loads and more complicated operations as the labs that use them expand their services and capacity. A LIMS can adapt to increasing amounts of data generated by new R&D technologies by expanding its storage and processing capability to the application server. Another example is functional scalability. Companies can add new workflows or modules as the lab’s requirements grow and change, or if new labs are added to the LIMS instance.

Benefits of Configuring a Preclinical R&D LIMS in Your Lab

With the right configuration, LIMS plays a key role in expediting preclinical research and development by helping labs be more efficient, compliant, and competitive. The benefits to preclinical labs mentioned here call for varying degrees of configuration. Some may be as simple as toggling a button during setup; others will require the help of someone with both expertise in your LIMS product and preclinical domain knowledge. For those kinds of configurations, engaging the services of a qualified third-party consultant may be a wise investment.

Don’t have a LIMS? CSols can help you quickly evaluate LIMS vendors and choose the right one for your preclinical lab.

If you already have a LIMS, is it configured to provide optimal benefits for your R&D lab? CSols can help assess your current system and recommend changes that enable your preclinical lab to go farther, faster.

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