Pre-clinical research refers to the stage of scientific investigation that occurs before testing a new treatment or intervention in humans. This phase of research typically involves experiments conducted in laboratories and on animals to gather preliminary data about the safety, efficacy, and potential mechanisms of action of a new drug, therapy, or medical device. During pre-clinical research, researchers aim to understand how the proposed treatment works, its potential side effects, and its overall safety profile. This stage also helps researchers determine appropriate dosages and treatment regimens for subsequent human trials.

The stakes in pre-clinical research are high as this serves as the foundation on which groundbreaking discoveries and life-saving treatments are built. Consequently, the consequences of data integrity breaches and non-compliance with regulations are not mere footnotes but potential deal-breakers. A compromise in data integrity and regulatory pitfalls can derail promising studies, erode trust in research, and even lead to legal repercussions. In a field where accuracy and ethical standards are paramount, safeguarding data integrity and compliance is non-negotiable.

What is Data Integrity and Compliance?

Data integrity in pre-clinical research is the assurance that data is accurate, reliable, and consistent throughout its lifecycle. Compliance, on the other hand, refers to adherence to the regulatory requirements and industry standards that govern research practices. These twin pillars are indispensable because they ensure the validity and credibility of the research outcomes.

Ways to Ensure Data Integrity and Compliance in Pre-Clinical Research

Here are some ways to ensure data integrity and compliance in preclinical research:

• Develop Standard Operating Procedures (SOPs): Having a comprehensive SOP that outlines how each step and procedure should be carried out is imperative. This includes data collection, storage, and management procedures. Consistency in data handling is crucial to avoid discrepancies and ensure compliance with industry standards. It is important to ensure that all team members are well-versed in these SOPs: consider regular refresher training sessions to keep everyone up to date.
• Conduct Regular Data Validation and Audits: It is important to regularly validate data for accuracy and completeness and to conduct internal audits as an added layer of assurance. This process should be meticulous, involving thorough cross-checks and systematic reviews to identify and rectify inaccuracies.
• Conduct Regular User Training: Train your research team in data management and compliance. A well-trained team is less likely to make inadvertent errors that could jeopardize the integrity of your data. Training should extend beyond the basics; it should encompass an understanding of the specific regulatory requirements for your field and the importance of compliance.
• Version Control and Documentation: Maintain a robust version control system to track changes to your data and documents. Document all procedures, changes, and deviations. This not only ensures data traceability but also assists in regulatory compliance. A strong data management system should encompass all aspects of your research process, from data collection to reporting, providing a comprehensive record of your work.
• Conduct Third-Party Audits: Consider involving third-party auditors who can independently assess your data integrity and compliance measures. Their fresh perspective and expertise can help identify areas of improvement that might be missed in internal assessments.

The Crucial Role of Preclinical LIMS in Maintaining Data Integrity and Compliance

A Laboratory Information Management System (LIMS) plays a vital role in ensuring data integrity and compliance in pre-clinical research. It offers a centralized platform where data can be collected, stored, and managed systematically, eliminating data silos. Here are some important roles that a LIMS for clinical research plays:

• A preclinical LIMS supports the strict requirements of data integrity by providing extensive features to facilitate compliance with regulatory standards and industry best practices.
• A LIMS helps maintain data integrity through the enforcement of data entry standards and validation checks. This ensures that the data collected is consistent, accurate, and compliant with predetermined criteria. 
• A LIMS is equipped with access controls and audit trails, which track data entry and modifications, enhancing transparency and accountability. For example, if a user makes changes to data, the system records who made the changes and when, making it easier to trace and investigate any anomalies or breaches. 
• A LIMS additionally authenticates users by requiring them to digitally sign before adding new data or initiating any modifications to the existing data. 
• A cloud-hosted LIMS provides the benefit of remote accessibility, enabling researchers to input and access data securely from anywhere.
• A cloud-hosted preclinical LIMS has robust security measures in place, such as encryption and authentication protocols, to safeguard sensitive data. The cloud infrastructure also ensures automatic backups, reducing the risk of data loss due to technical issues, theft, or natural calamities.
• A cloud-hosted LIMS reduces the total cost of investment by eliminating the upfront costs associated with traditional IT infrastructure. This means that even smaller research teams or organizations with limited budgets can leverage the power of LIMS without the significant capital expenditure. 

A LIMS plays a crucial role in facilitating compliance with regulatory standards. A LIMS enables efficient document management and tracking of every step of the research process, from sample collection to analysis and reporting. Additionally, a LIMS automates workflows, enforces standard operating procedures, and incorporates validation checks to minimize human errors and ensure consistency across experiments. Furthermore, a LIMS supports the generation of comprehensive reports, simplifying regulatory inspections and audits. A LIMS can integrate with laboratory instruments to automate data capture. Additionally, it helps manage instrument calibration schedules and records, ensuring that instruments are maintained in a state of compliance with regulatory requirements. A LIMS also helps in managing and scheduling staff training, enabling laboratory managers to assign tasks only to competent staff. 

Researchers can actively monitor trials in real-time through a LIMS, enabling prompt corrections when anomalies arise. Integrated with temperature sensors, a LIMS alerts researchers to deviations in sample storage temperatures, logging event details such as time, duration, and location. Additionally, by integrating with automated dispensing equipment for lab animals, a LIMS detects and notifies personnel of dosage deviations, facilitating immediate response and assessment. Furthermore, the built-in analytics tools of a LIMS offer valuable insights into trends and performance indicators, enhancing informed decision-making.

With such capabilities, a LIMS not only enhances data integrity and compliance but also drives efficiency and reliability in pre-clinical research, making it an indispensable tool in the pursuit of groundbreaking medical advancements.

Conclusion

Ensuring data integrity and compliance is an unequivocal imperative in preclinical research. The consequences of data compromise can be dire, potentially jeopardizing the validity of research findings and delaying critical advancements in medical science. However, the adoption of a robust preclinical LIMS can help clinical researchers overcome obstacles and deliver quality and uncompromised results. 

Industry reports have repeatedly shown that the efficacy of a laboratory’s Quality Control (QC) processes influences the quality of its results. Clearly, QC isn’t merely a checkbox on a regulatory list; it’s the basic building block for ensuring laboratory results are scientifically sound and practically reliable. 

Consider a clinical diagnostic laboratory, where the impact of QC and effective management is most evident. Errors at any stage of ordering, collection, testing, and reporting can have profound consequences, leading to severe patient misdiagnosis. Hence, quality control within a laboratory should encompass all facets of laboratory processes and procedures.

This blog delves into six simple but essential principles integral to effective QC laboratory management.

Conclusion

Cultivating a culture of quality, empowering teams, utilizing meaningful metrics, maintaining quality standards, leveraging visualization tools, and promoting ongoing improvement, each principle contributes to the overarching goal of maintaining top-notch quality in laboratory operations. A LIMS software is not just an enabler but a critical asset in enhancing QC laboratory management, streamlining data tracking, providing real-time insights, and facilitating transparent reporting, thus empowering laboratories to uphold and proactively support quality standards. The takeaway is clear – while efficiency is important, it must not compromise the integrity of results. Laboratories must prioritize rigorous QC practices, leverage advanced tools such as LIMS, and embrace a culture of continuous improvement to deliver reliable results consistently.

Algal populations, integral to healthy aquatic ecosystems, take a troubling turn under specific conditions – elevated temperatures and high nutrient concentrations being primary catalysts. This deviation triggers the rapid growth or “blooming” of algae, leading to the production of toxins. These toxins have far-reaching consequences in water bodies, affecting not only human health but also posing risks to animals, aquatic ecosystems, and the economy at large.

Algal blooms disrupt the delicate balance of nature as they proliferate, causing fish kills, habitat degradation, and altering the ecological dynamics of affected regions. According to environmental assessments, Harmful Algal Blooms (HABs) have resulted in the closure of beaches and recreational areas, contributing to economic losses estimated at millions of dollars annually. Moreover, the toxins generated during HABs have been associated with various health issues, ranging from respiratory ailments to gastrointestinal illnesses. 

Cyanobacteria, also known as blue-green algae, are photosynthetic bacteria capable of harmful algal bloom formation. In 2014, the impact of a cyanobacterial HAB in Lake Erie reverberated, affecting the drinking water for more than 500,000 people in Toledo, Ohio. Subsequently, in 2016, a massive HAB in Florida’s Lake Okeechobee had widespread consequences, negatively impacting tourism and aquatic life. Given the multifaceted challenges posed by HABs, the identification and control of these blooms have emerged as critical priorities for environmental management and public health protection. Timely detection of HABs is essential for implementing effective mitigation measures and safeguarding water quality. Through proactive monitoring and laboratory analysis, stakeholders can gain valuable insights into the presence of algal toxins, nutrient levels, and other parameters crucial for assessing the risk of HAB occurrence in water bodies.

In this blog post, we will explore the vital significance of laboratories in identifying and controlling HABs in water sources.

The Role of Laboratories in HAB Detection and Control

Laboratories serve as frontline defenders against the threats posed by HABs through their ability to identify harmful algal species and quantify associated toxins accurately.

With techniques such as microscopy, molecular analyses, and innovative sensors, laboratories can accurately identify algal species responsible for HABs and quantify the levels of associated toxins. Specifically, in the case of cyanobacterial HABs, methodologies like enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR) enable precise detection of cyanotoxins, aiding in targeted management strategies.

Moreover, with regular monitoring and early detection, laboratories contribute significantly to the proactive management of HABs. Routine sampling and analysis allow for the identification of algal blooms at their onset, enabling timely intervention and mitigation measures. Early detection is crucial, particularly for cyanobacterial HABs, as certain toxins can rapidly contaminate water supplies, posing risks to ecosystems and public health. 

In addition to identification, labs play a crucial role in controlling HABs by analyzing water samples using advanced techniques to assess toxin levels and understand environmental factors. This knowledge contributes to the development of targeted control measures, including the selection of algaecides, optimization of water treatment protocols, and evaluation of intervention impacts. Furthermore, labs provide actionable insights to water treatment plants and policymakers, guiding tailored approaches and facilitating the formulation of regulations covering water quality standards, monitoring requirements, and preventive measures for a comprehensive governance framework addressing HAB challenges.

Lab Techniques for HAB Identification

Laboratory methods can not only pinpoint the presence of specific algae responsible for HABs but also quantify the levels of toxins, providing critical data for informed decision-making. Here, we look at three such methods:

1. Total Kjeldahl Nitrogen (TKN) Method: TKN is a laboratory method designed to measure the collective content of organic nitrogen and inorganic nitrogen such as nitrate and nitrite in water samples, providing valuable insights into nutrient sources that can contribute to algal proliferation.

   In this method, the sample is first digested using concentrated sulfuric acid (H2SO4) along with a catalyst, typically copper sulfate (CuSO4), and a reducing agent like potassium sulfate (K2SO4). This digestion process converts organic nitrogen compounds into ammonium ions (NH4+). Next, the ammonia produced is distilled from the sample using a strong base, such as sodium hydroxide (NaOH), and collected in an acidic solution. Finally, the collected ammonia is titrated with a standardized acid solution, typically hydrochloric acid (HCl), to determine the nitrogen content of the sample.

   TKN analysis plays a crucial role in identifying nitrogen compounds derived from various sources, including wastewater and agricultural runoff. Its popularity lies in its effectiveness as an indicator of potential nutrient influxes that may stimulate algal growth. While nitrogen is traditionally considered secondary to phosphorus in stimulating algae growth, TKN’s significance has gained recognition in recent years, particularly in managing blue-green algae associated with HABs.

   Laboratories employ TKN analysis to gauge the presence of immediately digestible forms of nitrogen, offering insights into the potential risk of algal blooms. The TKN method is particularly useful for analyzing complex organic samples where nitrogen may exist in various forms, providing a comprehensive measure of total nitrogen content.

2. Total Phosphorus (TP) Method: TP analysis is integral in assessing water quality, specifically focusing on the concentration of phosphorus in various chemical forms within a water body. As phosphorus sources become more widespread, stemming from urbanization and agricultural land development, understanding the impact of TP on nutrient enrichment and its role in stimulating algae growth is crucial.

   The Kjeldahl digestion method for TP mirrors the approach used for TKN, involving sulfuric acid and a sample to convert various phosphorus forms into orthophosphate. In the laboratory, the analysis progresses to react with a solution, forming phosphomolybdic acid. The resulting complex is proportional to the amount of phosphorus in the solution.

   Laboratories can choose from various methods for analyzing phosphorus in samples, including low-level phosphorus analysis and total phosphorus analysis via UV persulfate digestion. The choice of method depends on factors such as the nature of the sample, the required detection limits, the available equipment, and the laboratory’s standard operating procedures.

3. Geosmin & MIB Method: Geosmin and 2-methylisoborneol (MIB) are naturally occurring compounds produced by certain bacteria and algae, notably cyanobacteria, often associated with HABs. While these compounds themselves are non-toxic, they play a crucial role in causing taste and odor problems in water. Humans are highly sensitive to these compounds. When present in drinking water, geosmin and MIB can impart an earthy or musty smell, leading to aesthetic concerns among consumers.

   To identify and quantify geosmin and MIB, laboratories employ advanced techniques such as EPA Method 524.3. This method involves the extraction and analysis of these compounds using gas chromatography-mass spectrometry (GC-MS). By leveraging the high sensitivity and selectivity of GC-MS, this method allows for the detection of geosmin and MIB at levels as low as one part per trillion, meeting the stringent drinking water regulations.

Why Water LIMS For Labs?

The logistics involved in water testing, especially when addressing the complexities of HABs, require great attention to detail. A technician’s task is not just about obtaining a water sample; it involves ensuring the right specimen container, accurate labeling of the container, accessioning samples, choosing and performing the right tests, and reporting accurate test results after validation. This is where a Laboratory Information Management System (LIMS) comes in. A water LIMS provides an integrated solution to streamline the entire process. It helps manage samples, generate sample labels containing unique barcodes, register samples and subject them to the right tests, streamline testing and quality control (QC) processes, validate test results, and report results to clients and regulatory authorities. Moreover, it offers flexibility by allowing laboratories to configure their software to meet specific needs, including managing standard operating procedures (SOPs), staff training, instrument calibration, documents, reporting requirements, and more. Furthermore, a LIMS supports integration with analytical instruments such as GC-MS and sensors, as well as with third-party software such as Enterprise Resource Planning (ERP) software and billing software.

The role of a water LIMS goes beyond just managing data; it serves as a centralized hub where all data, documents, and reports coexist seamlessly. This eliminates disconnected data silos that occur when you have multiple departments and use multiple instruments, sensors, and software for managing your lab operations. 

A water LIMS not only enhances the efficiency of laboratory operations but also contributes significantly to the accuracy and reliability of data crucial for monitoring and addressing HABs. 

Conclusion

Laboratories, armed with advanced techniques, are instrumental in protecting ecosystems against the threats posed by HABs and protecting public health. The timely detection and precise quantification of algal species and associated toxins provide invaluable insights for proactive management and mitigation measures. In addition to detection and identification, laboratories actively contribute to the development of control strategies. The integration of a water LIMS streamlines the processes involved in addressing HAB complexities. A water LIMS ensures accuracy, efficiency, and seamless management of data, from sample collection and analysis to reporting of test results, contributing to the overall reliability of information crucial for monitoring and addressing HABs. 

In the face of multifaceted challenges, laboratories and water LIMS systems together stand out as indispensable resources for safeguarding water quality.

In the dynamic world of clinical research, where breakthroughs hold the key to advancing medical knowledge, time is a precious resource and effectively managing it is a persistent challenge. The landscape is fiercely competitive, and swift and efficient management can be the dividing line between pioneering treatment and languishing in missed opportunities. For instance, clinical trials are no strangers to delays. Yet, delays can be the deciding factor separating a market-leading medical innovation from an obscure also-ran contender. McKinsey’s insights underscore this reality, revealing that a product entering the market second is poised to face a daunting 6% market share disadvantage a decade down the line – a stark reminder of the lasting impact that delays can have. Navigating the complex world of clinical research demands not only scientific acumen but also meticulous orchestration of data and processes. This is where a state-of-the-art Laboratory Information Management System (LIMS) emerges as a transformative ally, offering a comprehensive solution to streamline and optimize every facet of clinical research. In this blog, we delve into five critical capabilities that shape a standout Clinical Research LIMS system.

1. Acceleration of sample integration and efficient sample management

In high-throughput clinical labs, expediting sample registration and associating samples with correct tests is a vital role of a LIMS. A LIMS automates and facilitates secure storage of annotated sample data, barcode-based sample tracking, label printing, and comprehensive management of sample genealogy and sample processing workflows. This empowers efficient workflow management and ensures the integrity of sample information throughout the testing journey.

 2. Flexibility in the configuration of the Clinical Research LIMS

Clinical research labs perform a wide range of studies, each with distinct protocols, sample types, and analytical methods. This necessitates deploying information management systems that offer ample flexibility to mirror workflows, no matter how complex they are. A flexible LIMS enables efficient configuration of data fields, samples, participants, study types, and reporting templates to align with specific study protocols. This adaptability empowers users to incorporate modifications in workflows, such as introducing new categories of tests. With a LIMS that can organically evolve alongside the lab’s requirements, research facilities can embrace innovation and seamlessly expand their operations without being constrained by technology limitations. This strategic approach not only future-proofs the lab’s capabilities but also empowers researchers to navigate a shifting landscape with agility and precision.

3. Support for compliance with regulatory guidelines

Clinical research laboratories are required to meet regulatory obligations such as mandates set forth by ICH-GCP, HIPAA, 21 CFR Part 11, besides regional compliance. These regulations pertain to the precision and dependability of tests and the safety of research participants, and require strict adherence to a predefined set of criteria. Consequently, a LIMS must support and align with these standards, ensuring seamless compliance. Meeting these criteria ensures the reliability and accuracy of testing procedures, besides the safety of patients through different phases of clinical trials. But that’s not all. Maintaining the confidentiality of data is also a critical focal point within clinical laboratories. Regulations such as HIPAA require labs to safeguard patients’ medical and demographic data from any unauthorized use. To guarantee the security of patient data, a LIMS should allow granting users access solely to pertinent information, adhering to a need-to-know basis. An indispensable attribute of clinical LIMS is an audit trail, which monitors data access and modifications. These features collectively underscore LIMS’ commitment to upholding data privacy, reinforcing the protective framework for patient information in clinical settings.

4.  Orchestration of clinical research studies

A modern clinical research LIMS is integral to effective study management as it seamlessly orchestrates various components of the research process. It empowers researchers to effortlessly manage clinical studies, intricately associating them with pertinent samples, participants, and designated study leaders. For instance, each clinical trial is different in its number and type of participants, its duration, its objective, the samples, and consent requirements. An effective clinical LIMS enables establishing and outlining the specifics of every clinical trial, including its parameters, protocols, ethical considerations, collection schedules, and study in charge. Furthermore, a LIMS empowers users to generate tailored study reports, providing comprehensive insights into critical aspects of each research.

5. Overall lab management

A key attribute of a clinical research LIMS system lies in its comprehensive lab management capabilities, which can be categorized into the following key areas:

• Inventory management: A clinical research LIMS helps keep tabs on the whereabouts and availability of items such as reagents and other consumables in a clinical research lab. It keeps a close watch on expiry dates and sets up reorder notifications for utmost convenience.
• Instrument management: A clinical LIMS monitors the operational status of instruments within a laboratory. It schedules calibrations and maintenance routines based on staff workload and instrument usage, ensuring optimal uptime and resource allocation.
• Document management: A LIMS enables users to effortlessly oversee various documents, including procedure manuals, instrument maintenance guides, standard operating procedures (SOPs), validated test methods, and instructional manuals. Additionally, it facilitates access only to authorized personnel.
• Lab health: A clinical LIMS system helps lab managers gain insights into and manage all resources within a clinical lab. Its dashboards provide an overview of the lab’s current status, aiding in accurate timeline assessments and resource allocation for ongoing and upcoming projects.

Conclusion

The world of clinical research is marked by fierce competition, and the difference between trailblazing and trailing behind often lies in efficient management. Clinical research laboratories can no longer afford to remain on the fence about adopting a clinical research LIMS system. Sample integration acceleration, configuration flexibility, regulatory compliance support, study orchestration, and holistic lab management are some of the capabilities that make LIMS a steadfast ally for efficient management in a clinical research laboratory. As the clinical research landscape evolves, the question is no longer whether to embrace LIMS; it’s how to improve operations by integrating its transformative power into the heart of research operations.

The field of environmental testing has evolved significantly in the last decade and alongside it, the pressure to adapt to the shift has landed squarely on laboratories that test environmental samples. Laboratories need to perform a diverse range of analytical tests on environmental samples such as air, water, soil, and wastes (liquids, solids, or sludges). At the same time, laboratories have not been spared the economic upheavals that have cut across industries following the pandemic-initiated global recession. This has come with market consolidation and declining profitability. However, things are not as bad as they may seem. The market size for environmental testing is expected to surpass $17 billion by 2030, from $8 billion in 2023. What laboratories need is a lifeline to tide them over the recession period and accelerate productivity. In this case, leveraging technology seems to be it.

Here are three technological trends that are expected to gain momentum in 2023 and thereafter.

1. Automation of Laboratory Processes

While most environmental laboratories have already adopted some form of automation, we expect to witness an even greater uptake in 2023 and beyond.

Environmental laboratories face a myriad of challenges including the need to cut back on operational costs as well as a shortage of skilled and competent staff. At the same time, it is expected that the demand for environmental testing will grow exponentially in terms of volume and diversity of tests. Furthermore, environmental testing laboratories need to follow several regulatory guidelines such as NELAC (TNI), ISO 17025, RCRA, CERCLA, GLP/GALP, UCMR, CFR Title 40, CWA, NPDES, RCRA, UIC, besides state and local regulations. Managing huge volumes of test requests and data generated from them while meeting regulatory compliance can be overwhelming. This has created the need for informatics solutions.

Increasingly, more and more environmental testing laboratories are opting to automate entire workflows to maintain data integrity and eliminate manual errors. This includes processes associated with samples, tests, and data management as well as management of lab instruments, software, Standard Operating Procedures (SOPs) and personnel.

Automation presents several benefits, including data accuracy, the efficiency of processes as well as increased output. It also reduces the administrative workload and allows laboratory staff to focus on more specialized tasks. While the initial cost of switching from manual processes to automated systems can be high, this is likely to yield higher returns in terms of profits in the long run. Fortunately, automation technology for laboratories is now widely available, and consequently, automation has become relatively affordable for even small laboratories with meager budgets.

2. Cloud Computing

Cloud computing supports automation by providing remote and secure access to several IT resources that are hosted in the cloud. A survey conducted by Environmental Business International (EBI) showed that over 50% of environmental companies are planning to invest in cloud computing (IoT) in the 2020s.

Cloud computing allows laboratories to access computing services such as servers, databases, and software over the Internet. It enables real-time collaboration and cost-saving through economies of scale. Laboratories can easily store and access data from any location and at any time. Modern in-the-cloud systems, such as a cloud-based Laboratory Information Management System (LIMS), use world-class technology to beef up security and provide automated timely security updates. In multi-laboratory companies, a LIMS can centrally store data of all laboratories and manage diverse workflows of all laboratories, thereby eliminating data silos.

3. Artificial Intelligence (AI) and Machine Learning (ML)

AI empowers computers with the ability to “think” and execute actions without human input. Environmental testing laboratories can leverage AI and ML to improve experimental design, quickly analyze test results of multiple tests, and make data-driven decisions that may take days if done manually. Just like automation, AI reduces human error in laboratory processes and boosts productivity. The Environmental Business International (EBI) survey showed that over 50% of environmental laboratories are planning to invest in AI.

Apart from AI, the integration of LIMS with Augmented Reality (AR) and Mixed Reality (MR) solutions helps environmental testing laboratories to see SOPs and record observations. All these technologies are intended to increase efficiency in laboratories and boost output in tandem with the demands of 21st-century environmental testing.

A Greater Demand for an Environmental LIMS Software

From a value of $1.85 billion in 2021, the LIMS industry is expected to reach a value of $3.5 billion by 2030, growing at a CAGR of 7%. In a survey that was conducted by EBI, 95% of environmental companies indicated that they have the intention to invest in a LIMS. Most of these companies strongly believe that information technology is necessary for digitally transforming lab operations and for the evolution of the industry to the next phase. An environmental LIMS software automates laboratory workflows by integration with all instruments and software and ties in with other technological trends such as AI and ML.

A LIMS also manages and streamlines the entire sample life cycle, from sample accessioning to reporting test results to customers and regulatory agencies. Furthermore, a LIMS enables laboratories to meet stringent regulatory guidelines, flag out-of-specification results, analyze trends across a set of samples, track deviations from SOPs, and centrally manage multi-laboratory data with ease.

Leveraging The Latest Tech Trends Using an Environmental LIMS Software

Environmental testing is a profitable and competitive niche, but with a fair share of challenges at the same time. Forward-thinking laboratories can use the latest technology trends to pivot their operations so they can meet the stringent demands of environmental testing. Tech trends to be on the lookout for in the coming years include the automation of most laboratory processes, wide-scale adoption of cloud computing, and the use of artificial intelligence and machine learning. At the same time, more laboratories are expected to implement a cloud-based environmental LIMS software to digitally transform and future-proof their operations.

It is quite common for clinical trials to face delays, and delays have almost become expected and acceptable. But unknown to many, clinical trial delays are not only costly but they also have a negative impact on patients’ health. This blog walks you through the common causes of delays in clinical trials and offers five tips to mitigate them.

Roughly, 85% of clinical trials experience some form of delay with about 94% of them being delayed by at least a month. Such delays constrain clinical trial budgets and in the long term, they shorten the patent window of a drug and hence minimize its profitability. The money lost to clinical trial delays has been increasing and is estimated to be in the billions of dollars.

Trial delays place an unnecessary burden on patients who have to wait for longer than they had expected. This may force some to exit the trial, and may cause even further delays to allow time for the recruitment of other participants. Delays in clinical trials cause delayed treatments and this may diminish patient outcomes. With all this in mind, it is imperative to understand the root cause of delays so as to come up with tenable solutions.

What are the Causes of Clinical Trial Delays?

Poor planning is at the root cause of most clinical trial delays. Clinical trials are dynamic and evolving and hence different factors must be considered in the execution of a successful trial. This means that proper planning must be in place. Delays in as many as 25% of all trials have been attributed to commercial barriers and operational issues. The increasing complexity of trials with a multiplicity of endpoints on most trials places undue pressure on researchers, and results in delays. Communication barriers may also arise when trials are being conducted in multiple locations. Site initiation delays due to missed dates and poor planning are common occurrences. Once the trial is underway, patient retention becomes a significant cause of delay with over 50% of patients not showing up for pre-screening or declining to give consent. Another 8% usually drop out along the way. Lastly, operating in a tough regulatory environment may significantly impede the progress of clinical trials.

How to Mitigate Clinical Trial Delays? Here are 5 Tips

Given the evolving complexities and regulatory hurdles in the clinical research environment, it can be difficult to beat all the odds that cause delays. However, here are five tips to overcome delays in clinical trials.

1. Ensuring Proper Planning

Most of the causes of clinical trial delays can be attributed to poor planning. It is important to run through the trial from end-to-end and troubleshoot potential problems prior to launching the actual trial. Establish a working relationship and pinpoint unique challenges at each study site. Furthermore, you need to ensure that all your team members are onboard and aware of all important dates of the clinical trial.

2. Prioritizing Compliance and Regulatory Requirements

Academic institutions and pharmaceutical companies have different requirements and protocols for reviewing clinical trials. Other regulatory requirements might also arise from the federal or state levels of governance. Failing to address these requirements in time may derail the clinical trial.

3. Having Appropriate Communication Channels in Place

Communication breakdowns cause misinformation and misunderstanding among the trial stakeholders. It should be clear from the start where instructions are taken from and how any information should be disseminated. Objectives and responsibilities of each party need to be defined clearly. To achieve this, it is important to have an information management system to minimize information and other communication errors.

4. Boosting Patient Retention

Delays in the system due to poor planning and communication breakdowns are a major cause of patient dropout. Patients need to understand the potential benefits versus risks of participating in the trial and be allowed to make an informed decision. Proper consent must also be taken prior to the trial. Clinical trial laboratories must take measures to boost patient retention through proper advocacy and communication.

5. Deploying a Laboratory Information Management System (LIMS) for Clinical Trial Management

A LIMS for Clinical Trial Management can help minimize delays in clinical trials by automating laboratory processes and streamlining workflows. A LlMS for clinical trial management manages samples and the associated patient information including consent, and supports regulatory compliance. Furthermore, it helps minimize delays in clinical trials and Contract Research Organization (CRO) operations.

Reducing Trial Delays Increases Profitability and Improves Patient Outcomes

The clinical research landscape has become increasingly difficult to navigate. Without proper planning, clinical trial delays are inevitable. This has hefty financial implications that are estimated to spiral into billions of dollars. When the entry of drugs to the market gets delayed, patient health is also jeopardized. Considering all that is at risk, it’s only prudent to seek tenable solutions to mitigate clinical research delays. A LIMS for clinical trial management automates workflows to reduce trial delays.

Most laboratories invest a huge amount of money in procuring laboratory equipment. Therefore, laboratory managers should take necessary measures to effectively manage such an investment.

However, laboratories around the globe face the critical issue of improper equipment calibration and maintenance. It does not mean that laboratory staff neglect equipment or put them in their backpacks. It indicates that maintaining equipment records and ensuring proper calibration and maintenance of equipment with vigilance is challenging.

What are the consequences of improper lab management? There are several. Some of them are as follows:

• Fast wear and tear of equipment
• Inaccurate test results
• Wastage of an enormous amount of time and money

Is there any solution to seamlessly manage laboratory equipment?

The answer is yes, it is a Laboratory Information Management System (LIMS). It maintains the efficiency of your lab’s instruments. With a LIMS in place, there is an assurance among lab staff that equipment will:

• Receive timely maintenance
• Get proper monitoring of performance over time
• Save their time with automation
• Generate accurate and valid results

Thankfully, there are several ways through which a LIMS helps efficiently manage laboratory instruments. Some of them are as follows:

A. Integrate with Instruments

Today, automation rules the world and no laboratory across the globe can ignore it. A LIMS can be integrated with laboratory instruments via an Application Programming Interface (API) or by mapping instrument-generated CSV/XLS files with the correct fields in a LIMS. This facilitates bi-directional data transfer between instruments and a LIMS, saving time and maintaining data integrity.

B. Manage Lab Equipment Schedule

It isn’t convenient for workers to arrange lab equipment for multiple tasks. With hectic schedules, keeping equipment free for sample processing or testing becomes challenging. A LIMS offers proper equipment scheduling by permitting only authorized personnel to reserve the equipment and access them when needed. A LIMS facilitates:

• Easy tracking of the equipment schedule i.e. when equipment is in use and when it is not
• Tracking equipment maintenance before or after use
• Monitoring whether an instrument is in service or not

C. Ensure Effective Equipment Upkeep

Some complex equipment requires daily or weekly maintenance for smooth functioning. Laboratory managers prefer receiving timely email reminders for proper upkeep of lab equipment daily or weekly or as per the predetermined schedule. In such a scenario, a LIMS provides daily updates for general cleaning and equipment upkeep by:

• Creating a log file after the completion of the maintenance work
• Recording equipment cleaning work performed by staff members with a date and time stamp and an electronic signature
• Storing maintenance-related documents for future reference

D. Identify Equipment Errors

It is possible that lab equipment sometimes malfunctions or does not work as expected. So, it becomes crucial for lab staff to maintain a deviation (or event) log. If they fail to record such events, it may lead to disastrous consequences and audit failures. A LIMS offers a system for the staff to enter key details that comprise vital data about equipment malfunctions and helps them to:

• Spot faults quickly and prevent future malfunctions
• Provide reliable information to the manufacturer and limit user error

E. Strengthen Data Security

With the advancement in online operations, the risk of data breaches and cyberattacks has increased manifold. It has become a daunting task to safeguard data and permit access to the data in a controlled way. A cloud-based LIMS software safeguards sensitive user data in several ways. Some of the ways in which a LIMS enhances data security are as follows:

• Authenticating users through a two-factor authentication mechanism.
• Restricting access to the system through log-in by either integrating it with Lightweight Directory Access Protocol (LDAP) for user authentication or providing access from an “identity server”.
• Implementing data security filters to thwart online hackers from searching and exporting data, thereby restricting access to confidential information.

Furthermore, several other new measures ensure high-level data security. The first is a yearly risk assessment that helps determine likely risk factors and take risk mitigation actions. Secondly, staff must be given periodic training to apprise them of the latest incidents of cyberattacks and measures to prevent them.

Wrapping Up

The equipment must be in good working order to carry out daily lab operations efficiently. The staff and managers must ensure that lab equipment is checked regularly. Furthermore, the implementation of a LIMS system improves laboratory control and transparency while increasing efficiency through process automation and better equipment management. A LIMS helps centrally manage all crucial information related to lab equipment and enables staff to schedule equipment calibration and manage maintenance data.

Nobody anticipated that the COVID-19 pandemic would result in a fundamental shift towards the remote working environment. Even clinical laboratories are switching to remote or hybrid work employment as the “new normal”. However, a clinical lab must implement a detailed work plan when operating in a remote setting. The laboratory must maintain its level of output and efficiency under challenging conditions so that personnel can work in remote places without any disturbances.

Several measures will help any clinical lab working in a remote setting to operate efficiently. Let’s venture more into it.

1. Working Efficiently from Geographically Dispersed Locations

When working remotely, laboratories can streamline their operations and reduce operational costs through:

• Creation of centralized teams to review data efficiently
• Utilization of agile resource models to recruit remote workers that can bring their experience to enhance productivity
• Elimination of the need to acquire a large physical space, thereby reducing expenses
• Provision of compliance and financial assistance

2. Conducting Field Work through a Remote Access LIMS

If your lab has a remote access LIMS that can be accessed using any Internet-ready device, conducting fieldwork, such as collecting samples and generating barcodes for tracking samples, can be easily accomplished. Moreover, staff working remotely for any clinical lab can capture patient data and transmit all data through a remote access LIMS to the lab in real time.

3. Offering Quick Healthcare Services to Patients

Who needs the best healthcare services at a fast pace? Of course, patients! By chance, several tools allow lab workers to evaluate past data instantly and check and deliver health updates to patients with 100% accuracy online.

The clinical setting has been made extraordinary by providing devices such as glucose meters to the patients and getting immediate updates that are beneficial to improve their health conditions.

Nevertheless, several healthcare professionals do not consider remote patient monitoring by laboratories a fit in today’s time and even consider it a waste of financial resources. Some of the drawbacks of remote clinical labs in their opinion are:

• Stagnant growth of the lab staff with not much learning will hamper their productivity
• Internet connectivity issues in remote areas can be a cause of concern for the smooth provision of healthcare services

Challenges Lab Managers Face in Remotely Managing a Clinical Diagnostic Lab

In current times, patients are more health conscious and demand regular diagnoses and checkups. Though laboratories are working hard to bring the best health services to people, they still face challenges while working remotely. Some of the most common challenges that global diagnostic labs face are as follows:

1. Longer Turnaround Time (TAT)

When working at remote locations, sometimes, labs depend on 3rd party processing units, which delays the delivery of test reports to patients. Similarly, they may face challenges in tracking samples and TAT effectively. The practical solution for online working staff is to utilize a remote access LIMS for fast-tracking and monitoring processes and leveraging automation to deliver test results to patients via SMS, emails, or a patient portal.

2. Managing Daily Stock

Managing and controlling daily stock is challenging, which can create trouble for lab staff. The best solution is to deploy a LIMS or inventory management software for managing stock and sending alerts when the count of inventory items falls below a specified threshold limit. It can be done from anywhere by the lab workers and will help in efficiently managing lab inventory.

3. Handling Samples in an Appropriate Way

The vital aspects of lab operations are sample tracking and handling, which remote working teams struggle to manage. If left in the lurch, it may severely impact service quality and may result in loss of samples. The way forward is to use barcoded samples and connect them with your lab software.

4. Data Confidentiality & Sharing

Remote lab teams always have a shortage of skilled staff, which might result in the online theft of sensitive patient data and thus tarnish the reputation of the respective lab. To counter it, labs can consider providing permission-based access controls via a LIMS software solution. It will offer a secure password for each employee and ensure confidential data remains protected.

What Methods Lab Managers Should Undertake for the Smooth and Efficient Running of Remote Clinical Diagnostic Labs?

For a diagnostic lab to operate smoothly and effectively, it is vital to provide exceptional results without exceeding deadlines. So, there are some practical measures that lab managers must implement to carry out the operation in an effective way.

1. Trust the Team to Achieve Tasks Successfully

Remotely operating a lab is a tedious job. Every staff must get training to uphold best practices as per the industrial standards and conduct lab functioning efficiently. Besides, trusting them by giving autonomy will boost their morale and improve overall performance.

2. Recruit a Remote QA Lab Assistant

In a laboratory setting, quality is a must. Hiring a QA manager will ensure better quality assurance by continuously reviewing data and guiding the staff to follow Standard Operating Procedures (SOPs).

3. Aptly Track Key Performance Indicators (KPIs)

Thanks to LIMS, it is now possible to accurately show how a lab is performing concerning its stated goals. Furthermore, working remotely necessitates establishing priorities for finding KPIs such as:

• Monitoring of the environment
• Identifying the lab’s requirements
• Solving a specific problem

Apart from it, they will help lab managers find answers to the following questions:

• What to measure that encourages and motivates the team?
• How to ensure setting achievable objectives for the remote team?
• Will the KPIs drive towards adopting new innovative changes?

How Does a Cloud-Based Diagnostics LIMS Serve as a Central Hub for Remotely Managing Modern Clinical Diagnostic Labs?

A cloud-based Diagnostics LIMS is valuable for clinical laboratories as it can help lab staff digitally record and track results and workflows precisely. In modern times, it has acted as a central hub by enabling staff to accomplish experiment write-ups, analyze lab data, see data patterns and offer information for regulatory dossiers with excellent efficacy.

Wrapping Up

The new reality of futuristic clinical laboratories is remote working as the younger generation yearns for more flexibility with a perfect work-life balance! So, the onus is on the clinical lab professionals to make remote working more efficient and safer. They must also incorporate cloud and networking-based digital solutions that will assist them in producing quicker, better, and higher-quality healthcare results with 100% efficiency.

Scientists are only beginning to understand the multifactorial nature of diseases, but with large-scale biobanking, it may be just a matter of time before the dots connect. Genomics is paving the way for precision medicine and suitable treatment options for rare and difficult-to-treat conditions. This calls for large population-based biorepositories reflecting gene-gene and gene-environment interactions over time. If any success is to be achieved, there’s a need for international collaboration to achieve the required statistical power. This blog discusses the need and relevance of population biobanks as key drivers of clinical research in the future.

What is a Population Biobank?

A population biobank is best described as donations of thousands of biological specimens collected from members of the general population who might or might not be suffering from any disease. Most of these biological specimens are genetic material. However, a population biobank should not be confused with a genetic biobank which is a biorepository that only handles DNA material in order to understand the genetic determinants of disease, regardless of whether the samples were collected from the general population or not.

Population biobanks play a major role in identifying and analyzing genetic susceptibility to diseases and how lifestyle and environmental factors contribute to diseases. Population biobanks facilitate this by enabling researchers to analyze molecular data as well as the associated data such as clinical, imaging, and lab reports. A number of countries are already in the process of setting up population biobanks.

The Human Genome Project Laid The Foundation for Population Biobanks

The highly acclaimed Human Genome Project provided the stage for major breakthroughs in precision medicine, having successfully managed to sequence the entire human genome. This scientific miracle made it possible for researchers to begin to explore the link between genetics, disease, and response to treatment. However, translating this preliminary understanding into clinical benefits remains a challenge. A population-based approach to biobanking will give scientists multiple, varied and unbiased samples that will allow them to explore complex disease susceptibility genes.

Population Biobanks Are Powerful Tools in the Prevention of Chronic and Rare Diseases

Population biobanks play host to millions of genetic material as well as the related lifestyle, environmental, and clinical information. Researchers are able to analyze all this information and identify multifactorial causes of disease. This may provide breakthroughs in the treatment of chronic diseases such as Alzheimer’s, schizophrenia, cancer, diabetes, and asthma among others. This may also help scientists to establish triggers for adverse outcomes such as congenital birth defects and preterm births.

Population Biobanks Can be Used to Estimate Allele Frequency

Because of the diversity of varied specimens (from a large cross-section of participants from different ethnicities) in population biobanks, researchers are able to estimate allele frequency. This is the proportion of people in a population with a specific gene frequency that is instrumental in understanding the interplay between genetic and environmental factors and disease causation.

Population Biobanks Provide Modern Tools for Disease Prevention

In spite of major breakthroughs in genomics, their translation into clinical benefits has remained a mirage. Population biobanks are however promising to translate discoveries at the genetic level into a better understanding of complex diseases and hence the discovery of new and better drugs. What has been discovered from genomics so far has not been sufficient to alter current recommendations for patient care unless on a case-by-case basis. Research driven by population-based biobanking will bridge this gap and allow scientists to exploit the interplay between genetics and environmental risk factors for diseases. This research is needed not only for drug development but also for devising disease prevention strategies as well.

Role of a Biospecimen Management System in Population Biobanks

Population biobanks handle and process a ton of samples and sensitive patient data that’s the bedrock of clinical research. A Biospecimen Management System, also known as a Laboratory Information Management System (LIMS), offers a turnkey solution for labs through automation. A biospecimen management system offers end-to-end sample tracking and management and streamlines the entire biobanking workflow. A cloud-hosted biospecimen management system ensures remote access to biobank data and promotes collaboration while at the same time guarantees maximum data protection and security.

How Population Biobanks Can Shape the Future of Clinical Research

The world is at an unprecedented time with the evolution of -omics and precision-driven medicine. However, translational research remains elusive. Population-based biobanks store large volumes of biosamples harnessed from the general population. Population biobanks enable researchers to analyze genetic biomarkers in relation to medical history and environmental factors. They go a step further to offer information about allele and gene frequency in a population. The integration of population-based genomics with modern biobanking will provide scientists with the rare opportunity to tackle rare and complex diseases right at the genetic level. A biospecimen management system streamlines and automates operations of population biobanks, helps them overcome regulatory challenges, and assures data security at all times.

A Laboratory Information Management System (LIMS) is a laboratory software that helps automate sample and data management and also streamlines lab processes and facilitates integration with other systems. A modern cloud-based LIMS allows a lab to generate numerous concise and professional reports that can be used to guide the lab’s decision-making process. However, one needs to understand how to make the generated data and metadata actionable so as to derive the most value from the LIMS.

Here are six LIMS reporting tips to make your data actionable.

1. Understand the Different Kinds of LIMS Reports

A LIMS generates different kinds of reports from the data imported into it. Here is a breakdown of the most important ones that you should look for in a LIMS:

Analytical Reports

This type of report combines different lab inputs, such as the number of samples registered, tests carried out, and turnaround time (TAT), for comparative analysis. Analysis reports include test analytics reports and overall TAT reports.

Operational Reports

There are numerous types of reports produced by a LIMS, and they depend on the unique needs of a lab. The operational reports include reports such as completed tests, approved results, canceled results, lab performance results, and inventory reports among others.

Financial Reports

Financial reports are very important as they help a lab to keep track of the day-to-day revenues and expenditures. Financial reports generated from a LIMS include daily collections, physicians’ revenues, bill settlements, and pending bills among others.

2. On-Demand Reports

LIMS reports have traditionally been generated on-demand. This means that the systems administrator pre-configures templates and the lab staff members can populate the templates with fresh data and generate new reports. The good thing about this type of report is consistency. On the flip side, this type of report is rather rigid. Some LIMS allows flexibility through ad hoc reporting. This enables lab managers to customize reports by allowing them to add necessary elements to suit regulatory and customer requirements. However, the system administrator needs to ensure that no data corruption or misrepresentation occurs in the process.

3. Scheduled Reports

A LIMS can also generate scheduled reports at regular time intervals or based on pre-configured metrics. For example, a lab manager may want to keep track of the lab’s performance at a weekly or monthly interval. The LIMS will generate such a report based on the scheduled time intervals and automatically send out the report to the lab manager and other concerned persons.

4. Customize Your LIMS Dashboard

The dashboard of a LIMS is often an underutilized resource because most people do not understand the power that can be harnessed from real-time data visualization. Role-specific dashboards, for example, can be tailored to display Key Performance Indicators (KPIs) at a glance and hence help ensure that all lab activities are goal oriented. A LIMS dashboard can be configured to display all critical parameters that must be monitored constantly. For example, it may display the samples in a lab and at what stage of processing they are in. It may also display lab inventory, inventory items that are on the verge of depletion, and staff training records.

A key challenge with the LIMS dashboard is data overload especially when the data has been derived from several complex records generated over time. It is critical to always refresh the dashboard so that it displays the current data at all times.

5. Alerts

A LIMS can be configured to send out alerts when certain conditions are met or exceeded. However, alerts need to be well planned to avoid what is known as “alarm fatigue“, a common occurrence in healthcare. If you’ve been to a hospital, you should be familiar with the incessant beeping of alarms that mostly go unattended. The same can happen when a LIMS is configured to send out too many alerts in the form of system notifications, emails, or text messages. It may be more efficient and productive to configure alerts to be sent out to specific people, for example, lab managers, or concerned staff members.

6. System Interfacing

Since a LIMS is the data center for a lab, it’s important to have it integrated with other systems such as Enterprise Resource Planning (ERP) software, Quality Management System (QMS), and Customer Relationship Management (CRM) software, among others. Integrating the LIMS with third-party data analysis tools can facilitate prompt downstream analysis and reporting that is instrumental for decision-making. Centralized data management will ensure consistency and make the data more actionable.

Leverage LIMS Reporting to Boost Your Lab Performance

You might have the best LIMS in the market, but if you fail to optimize it and make the data actionable, it will all be a waste. Making LIMS data actionable calls for several strategies. First, you need to understand the types of reports a LIMS generates and how and when to use each. You also need to understand how and when to set alerts. A LIMS dashboard can be configured to keep track of all the important parameters that should be within your reach at a glance. Lastly, make use of system interfacing to improve the performance of your LIMS and generate consolidated reports.