Monitoring is the linchpin that holds together the integrity of a clinical trial. It’s not just a formality, but a crucial component in safeguarding patient welfare, preserving data accuracy, and ensuring compliance with study documents and regulatory standards. By maintaining diligent oversight of study conduct, sponsors dedicate themselves to upholding the ethical principles of clinical research, bolstering public trust in the scientific community’s commitment to patient safety and data integrity.
In the fast-paced and intricate world of clinical trials, ensuring research site compliance is paramount to successful study outcomes. Sponsors who work in clinical operations understand this well. Their primary objective is to conduct trials on time, within budget, and in strict accordance with guidelines and regulations. For those who work in biosample operations, on the other hand, it’s imperative to have full oversight of patient samples, ensuring that at-risk samples or missing samples are able to be quickly identified and addressed.
Unfortunately, the intricacies of modern clinical trials have drastically complicated sponsors’ abilities to execute a robust and comprehensive monitoring strategy. We live in a world where breakthroughs in clinical research demand complex science — and that complex science demands complicated lab kits and sample collection schemes, as well as myriad labs, vendors, and clinical systems. These factors, while inevitable, drive research site compliance issues and hinder sponsor oversight.
In this guide, we’ll explore the pivotal role of centralized monitoring and risk-based monitoring in enforcing compliance; the challenges posed by complex clinical trials; the impact of disconnected stakeholders on your monitoring plan; and the inadequacies of traditional monitoring approaches. We’ll delve into the intricacies of lab kit management, sample management, protocol amendments, and the significance of research site standardization and training. We’ll also address the critical issue of data lag and offer solutions to improve the quality of biospecimen data.
Our overarching goal is to equip you with insights and strategies to enhance research site compliance. This journey will not only shed light on the challenges sponsors and sites face, but also introduce some solutions, culminating in a deeper understanding of how sponsors can elevate their monitoring plans and unlock real-time access to high-quality biospecimen data.
A growing number of sponsors are embracing solutions that enable more efficient and effective monitoring on their clinical trials. So what do these innovative approaches entail?
What role do centralized monitoring and risk-based monitoring play in upholding compliance?
When it comes to clinical operations and biospecimen management, sponsors need to embrace monitoring methodologies that: 1) offer a comprehensive, efficient approach to overseeing study activity, and 2) maximize the integrity of patient samples.
Traditional monitoring methods are being augmented by innovative approaches like centralized and risk-based monitoring. Centralized monitoring involves the remote evaluation of trial data and processes across all study sites, allowing for real-time oversight and intervention. When it comes to biospecimen data, centralized monitoring ensures that sponsors have instant access to critical sample metadata and sample tracking capabilities, reducing the risk of delays and discrepancies.
On the other hand, risk-based monitoring focuses on identifying and mitigating risks that could impact the quality and integrity of clinical trial data. By prioritizing resources based on risk, sponsors can allocate attention where it is most needed. This means embracing a more targeted and efficient approach to managing biospecimen data, ensuring that sample management activities are in compliance with the protocol, lab manual, GCP/ICH guidelines, and regulatory requirements.
Collectively, centralized monitoring and risk-based monitoring are essential tools for mitigating risks, enhancing compliance, accelerating timelines, and ultimately improving study outcomes. Finding tailored solutions that enable these advanced monitoring methodologies requires sponsors to evaluate the various elements that impact the efficiency and success of a clinical trial. Within the context of site compliance, this means seeking solutions that not only prevent site compliance issues from happening in the first place, but also make it easier for sponsors to quickly identify issues before it’s too late.
Let’s consider several factors that hinder research sites’ ability to be successful and cloud sponsor oversight into compliance issues.
Complex clinical trials are making sites’ jobs harder.
For sponsors that work in clinical operations and sample management, it should come as no surprise that the complexity of modern clinical trials poses significant challenges for research sites.
The design and execution of modern clinical trials are becoming increasingly intricate, driven by advancements in precision medicine and the growing complexity of disease mechanisms of action. The increasing demands for diverse sample types and complex logistics can strain site resources, intensifying hurdles faced by sites in managing patient samples and biospecimen data across intricate study protocols. Our blog, “How Do Complex Clinical Trials Contribute to Research Site Compliance Issues?”, explores these challenges in greater depth.
As trials become more complex, so do the challenges associated with monitoring them. From the initial stages of clinical trial planning and design to the meticulous execution of monitoring plans, sponsors must navigate many factors, including the creation and oversight of lab kits and sample management workflows — along with the integration of centralized and risk-based monitoring strategies to address these factors. Our blog, “4 Questions to Ask When Developing a Monitoring Strategy for a Complex Clinical Trial”, guides sponsors through key considerations for building a comprehensive monitoring plan.
This complexity introduces the need for a streamlined and integrated solution that can simplify site’s responsibilities and improve overall efficiency across all study stakeholders.
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Disconnected clinical trial vendors and study stakeholders are complicating site workflows — and your monitoring plan.
In clinical trials, collaboration is key — but the current landscape of clinical research makes this incredibly challenging.
Sites often find themselves in the middle of a complex web of labs, CROs, and tech vendors that provide essential services and support throughout the trial lifecycle. These vendors may have several touch points with sites; for instance, one vendor may be responsible for supplying the site with the lab manual and lab kits, while another vendor may be responsible for processing requisition forms, issuing lab queries, and testing patient samples.
It takes a village to run a successful clinical trial, but the sheer number of stakeholders that support a single trial can place a significant amount of strain on research sites. Imagine being a study coordinator who has to manage several clinical systems, lab kit vendors, sample shipments, and lab queries across various labs on a portfolio of dozens of trials. These complicated workflows bog down site efficiency and introduce the risk of significant compliance issues. For instance, a site may forget that a certain lab kit isn’t covered by automatic resupply, and therefore may run short of critical clinical supplies that are needed for an imminent patient visit. Sites may also ship samples to the wrong location by mistake. Our blog, “What Can Research Sites Do to Better Manage Multiple Clinical Trial Vendors & Systems?”, explores best practices for sites when it comes to managing the many key players involved in study execution.
For those in clinical and biosample operations, the increased risk associated with working with several vendors also necessitates a robust monitoring strategy that mitigates these very risks. However, the disconnected nature of our industry also hinders the seamless flow of biospecimen data. Traditional approaches often result in fragmented data sources, making it challenging to have a comprehensive, real-time view of biospecimen activities across all sites and labs.
For instance, consider the fact that sponsors and their vendors often lack visibility to the “first mile” of the biospecimen lifecycle — the site activities that occur before a sample is shipped. When study stakeholders don’t have access to this information, it can complicate sample investigations and make it more difficult to detect compliance issues until it’s too late. Our blog, “4 Questions to Ask Yourself as You Consider Clinical Trial Vendors”, explores other factors that sponsors should consider when it comes to vendor selection.
Solutions should address this challenge by collecting sample metadata in real-time as sites and labs perform study activities through both a site-facing platform and integrations with EDC, LIMS, and more. This ensures instant access to the biospecimen data that sponsors need, facilitating timely decision-making and improving overall compliance. Check out “Selecting Vendors & Systems That Enhance Clinical Trial Monitoring” for other characteristics that sponsors should look for as they weigh different vendors.
Effective management of clinical trial vendors requires clear communication and diligent oversight. By fostering strong partnerships and implementing robust vendor management practices into the monitoring plan, sponsors can ensure the smooth execution of clinical trials and optimize study outcomes.
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Research Site Best Practices for Collaborating with CRAs on Clinical Trial Monitoring
Monitoring strategies should prevent and quickly identify protocol deviations and violations — but traditional approaches are insufficient.
Protocol deviations can jeopardize the integrity of clinical trial data and compromise patient safety and burden. Identifying and addressing these deviations in a timely manner is essential for maintaining data integrity and study compliance. As we discuss in “Getting to the Root Cause of Avoidable Protocol Deviations and Violations”, disorganized lab kits, issues with sample management, and other factors can contribute to the preventable occurrence of deviations.
Ensuring site compliance goes beyond routine monitoring; it also requires strategies capable of preventing and rapidly identifying protocol deviations and violations. The effectiveness of a sponsor’s monitoring plan hinges on its ability to address these issues promptly.
Traditional monitoring approaches often fall short in providing real-time insights into biospecimen data. Delays in identifying protocol deviations and violations can have serious consequences, impacting the quality and integrity of your clinical trial. Consider solutions that offer instant access to high-quality biospecimen data, enabling proactive issue identification and reducing the risk of protocol deviations.
Fortunately, risk-based monitoring approaches can enable sponsors to prioritize resources and interventions based on the aspects of a study that are most susceptible to protocol deviations, ensuring that critical issues are addressed promptly and effectively. Solutions that enable centralized monitoring can also make it easier to address deviations from standard processes before it’s too late. To learn more, check out our blog, “3 Ways to Fine-Tune Your Clinical Trial Monitoring Strategy to Minimize Protocol Deviations”.
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Oh No! My Research Site Experienced a Protocol Deviation, and It Was Our Mistake! What Now?
Lab kit management lays the foundation for the most critical output of a clinical trial: data. Why isn’t this integral to every monitoring strategy?
Lab kit management is a critical aspect of clinical trial logistics, ensuring that research sites have access to the necessary supplies and materials to conduct research activities accurately and efficiently. From the tracking of lab kit orders to the management of inventory and expiration dates, effective lab kit management requires careful planning and coordination.
Sponsors who are responsible for study oversight require efficient and error-free lab kit management, but traditional approaches are often manual and error-prone in nature, leading to delays and data discrepancies. Many sites continue to manage clinical inventory using paper and spreadsheets, and even leading kitting vendors are limited in their abilities to support sites and sponsors with optimized lab kit management. In our blog, “What Does Clinical Trial Monitoring Have to Do with Lab Kit Management and Sustainability?”, we also explore how supply waste can have a significant impact on study budgets, research site resources, and the environment.
An effective lab kit management solution can set sites up for greater success, improving downstream data quality and overall efficiency of clinical operations. As we discuss in “From Chaos to Compliance: Transforming Clinical Trial Monitoring through Advanced Lab Kit Management”, by integrating robust monitoring plans into the inventory management process, sponsors can optimize lab kit distribution, minimize waste, and ensure compliance with study operations.
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Common sample management processes are prone to error and offer sponsors very little visibility.
Effective sample management is essential for maintaining the integrity of clinical trial data and ensuring the validity and reliability of study results.
Unfortunately, the way that most sites manage the collection, processing, storage, and shipment of samples is incredibly susceptible to risk. Most lab manuals are incredibly dense in nature, requiring site personnel to sift through dozens or hundreds of pages of instructions around inventory and sample management procedures. Some sites will templatize these instructions to simplify their sample management workflows, but even these workarounds are prone to error; consider the fact that site personnel may accidentally leave an important data point blank, or accidentally overlook a mandatory sample collection. This can lead to downstream queries, which can cause delays and serious gaps in clinical trial data.
Because many sponsors don’t currently have a solution for tracking site activity or integrating biospecimen data across various sites, labs, and biorepositories, implementing a sufficient monitoring strategy for patient samples can feel impossible. With samples changing so many hands, both at a site and after it leaves a site, sponsors may feel ill-equipped to monitor for any compliance issues that may arise. For example, consider the complicated logistics associated with managing and monitoring tissue samples, as we explore in our blog, “Clinical Trial Monitoring for Tissue Samples: Is Your Sample Management Strategy Sufficient?”
Centralized monitoring enables sponsors to track the movement and storage of samples across all of their sites, ensuring that specimens are collected, processed, stored, and shipped according to study requirements. By implementing comprehensive sample management solutions and leveraging advanced sample tracking technologies, sponsors can minimize the risk of sample-related errors and optimize data quality throughout the life of the study.
A unified platform that guides sample management workflows and captures sample metadata in real-time can reduce the risk of errors, while improving sponsor visibility into the entire biospecimen lifecycle.
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How Can My Research Site Prevent Sample Mishandling?
Protocol amendments in a clinical trial can cause site compliance issues. Shouldn’t your monitoring strategy take them into account?
Protocol amendments are inevitable in the ever-changing landscape of clinical research, necessitating careful planning and execution to ensure that sites can remain compliant with study changes.
Traditional monitoring approaches may struggle to accommodate the nuances introduced by protocol amendments — including changes to lab kits, sample collections, requisition forms, and more. Sponsors should look for solutions that integrate protocol amendments into their monitoring plan, ensuring that the right samples are always collected, the appropriate sample metadata is always captured, and samples are handled the right way.
By integrating risk-based monitoring approaches, sponsors can proactively identify potential impacts of protocol amendments on study conduct and data quality, enabling them to adapt monitoring plans accordingly. Effective communication and collaboration with research sites are also essential for facilitating the smooth implementation of protocol amendments. Consider processes that can supplement the rollout of new lab manuals and protocol versions by enforcing guardrails that ensure that site personnel never miss any of the changes resulting from a study modification.
Research site standardization and training allow your trials to run more smoothly and enable enhanced sponsor oversight.
There may be dozens, if not hundreds of sites that support one trial — but the one characteristic those sites all have in common is that they are all different. Even as sponsors try to roll out the same kits and lab manuals to research sites, sites may still have their own internal processes for managing clinical inventory, patient samples, and sample metadata. This in turn not only introduces more variability into a trial, but it also makes it difficult for sponsors to streamline operations and keep tabs on site activity in a consistent manner.
Standardizing research site practices and providing comprehensive training are essential components of successful clinical trial monitoring strategies. By establishing consistent processes and procedures across research sites, sponsors can minimize variability in how clinical inventory, patient samples, and site-generated data are managed.
Ongoing training and support also empowers research site staff to adhere to study requirements, recognize potential issues, and implement corrective actions effectively. For instance, supplementing amendment implementation with an augmented solution that makes integrating these amendments into site processes more seamless may improve site compliance.
Your samples can’t be processed, tested, or trusted without biospecimen data. How can sponsors reduce data lag and improve the quality of their sample metadata?
Biospecimen data — including the metadata associated with patient samples — play a crucial role in attributing samples to certain patients, communicating patient demographic information, ensuring that collection dates and times place samples within stability for testing, and ensuring that labs have the data they need to process samples downstream. What’s more, this data is critical to clinical operations and biosample management teams who may need access to this data to identify compliance issues and track study milestones. Additionally, sponsors rely on sample metadata to make study decisions around dose escalation, study amendments, sample analyses, funding, and much more.
Sponsors who lack real-time access to comprehensive biospecimen data may experience far-reaching impacts on their trials. Consider the negative impacts to patients, study milestones, time efficiencies, decision-making, and study budgets that can occur as a result of an insufficient strategy for capturing and streamlining the management, accessibility, and monitoring of sample metadata. Anytime there are gaps in this data, it can put the patient experience at risk. Database locks, interim/final analyses, and regulatory submissions can be delayed. Sites may not have access to critical lab results due to data-related lab queries, putting treatment decisions and patient inclusion/exclusion at risk. Sponsors may struggle to track study milestones and make informed decisions about their operations. Study stakeholders may lose countless hours to addressing queries, performing manual sample tracking, and more. All of these issues have significant monetary implications, ranging from more on-site monitoring and greater patient replacement expenses, to more overhead costs associated with running studies that are behind schedule.
Effective management of biospecimen data requires robust integrations and minimal data lag, ensuring seamless, real-time communication between data sources and systems. By leveraging database integrations with EDC, LIMS, and other clinical systems, sponsors can streamline data capture, analysis, and reporting, enhancing data integrity and accelerating the pace of scientific innovation. Solutions that capture sample metadata from sites in real-time can also dramatically improve the overall quality of the data that’s captured, while also accelerating the overall processing of samples downstream.
Learn more about solutions that can boost research site compliance.
Clinical trial monitoring is more than just a regulatory requirement; it is a cornerstone of successful study conduct. By embracing innovative monitoring methodologies such as centralized and risk-based monitoring and leveraging advanced technologies and solutions, sponsors can enhance research site compliance, optimize data quality, and ultimately improve study outcomes.
This guide only scratches the surface of clinical trial monitoring by offering a big-picture look at the various factors that influence site compliance and sponsor oversight. But what specific issues should sponsors be on the lookout for on their trials as they assess areas to improve their monitoring strategies? What are some potential solutions that enable the best possible centralized and risk-based monitoring approach?
To learn more about optimizing your clinical trial monitoring strategy and boosting research site compliance, download our e-book on “Optimizing Your Clinical Trial Monitoring Strategy to Boost Research Site Compliance,” and embark on a journey towards improving your data quality and accelerating your study timelines.
