Is Your Approach to Sample Risk Management Leaving Your Biospecimens Vulnerable? Here’s How to Fix It.

As a sponsor running a clinical trial, your success hinges on your primary and secondary endpoints — including safety, biomarker, and PK samples that must be collected and analyzed at precise intervals. 

But imagine that as your trial progresses, several samples are mishandled during shipment; others are processed incorrectly at the site; and a few simply go missing. The result? Irretrievable data, significant study delays, and increased burden on patients who may need to undergo repeat procedures. All of this could have been avoided with a more robust sample risk management strategy in place.

This scenario, unfortunately, is all too common in clinical trials. It’s easy to underestimate the complexity and potential risks associated with biospecimen management, leading to preventable issues that compromise the integrity of sample data. In this blog, we’ll explore the most common gaps in sponsors’ risk management processes for biospecimens and provide actionable steps to strengthen your approach.

1. You’re not assessing risk on all biomarker and PK samples

One of the most critical oversights in biospecimen management is failing to assess the risk associated with every sample — particularly biomarker and PK samples that are essential for determining the efficacy and safety of a treatment. Many sponsors focus on monitoring only a subset of their samples, often overlooking the fact that any sample mishap — whether it’s a lost or mishandled sample — can have severe implications for the study’s outcomes.

To mitigate this risk, sponsors must implement a process for assessing the risk level of every sample. This also means having visibility into every step of the biospecimen lifecycle, from collection and processing at the site to shipment and analysis at the lab. By ensuring that all samples have a plan in place to ensure they are accounted for and monitored, sponsors can proactively identify potential issues before they escalate.

2. You don’t have consistent/predetermined thresholds for categorizing at-risk samples

Without consistent and predetermined thresholds for categorizing at-risk samples, sponsors are left to react to issues on a case-by-case basis. This approach not only increases the likelihood that errors will occur, but also makes it difficult to detect issues until it’s too late.

Sponsors should establish clear criteria for what constitutes an at-risk sample. These criteria should be based on factors such as sample type, collection and processing protocols, shipment conditions, and lab requirements. By having these thresholds in place, sponsors can quickly assess the severity of any issues and take appropriate action to mitigate risks.

3. You aren’t assessing risk proactively and are instead reacting to issues once they have already happened

In the fast-paced world of clinical research, many sponsors fall into the trap of reactive risk management. They wait until an issue arises — such as a missed sample collection or a sample stability issue — before taking action. By that point, the damage may already be done, and the consequences can be costly.

Proactive risk management involves anticipating potential issues before they occur and implementing strategies to prevent them. This requires a thorough understanding of the biospecimen lifecycle and the potential risks at each stage. Sponsors should conduct regular risk assessments throughout the trial, updating their projections as new data becomes available and adjusting their strategies accordingly.

4. You aren’t monitoring in real-time for site compliance issues as they occur

Site compliance is another critical factor in biospecimen risk management. Non-compliance with sample collection, processing, storage, and shipment protocols can lead to data discrepancies, sample loss, and ultimately, compromised study results. However, many sponsors only become aware of these issues after the fact — when the damage has already been done.

Real-time monitoring is essential for identifying site compliance issues as they occur. By tracking site activities in real-time, sponsors can quickly detect deviations and take corrective action before they impact the study. This not only reduces the risk of non-compliance, but also ensures that any issues are addressed promptly — minimizing the potential for data loss.

5. You aren’t updating your risk projections to account for study changes

Clinical trials are dynamic by nature, with protocols and study requirements often evolving over time. However, sponsors may fail to update their biospecimen risk projections to account for these changes, leaving them vulnerable to unforeseen issues.

For example, a protocol amendment may introduce new sample collection procedures or change the timing of sample shipments. If these changes aren’t reflected in the sponsor’s risk management plan, they may overlook potential risks and fail to implement necessary safeguards. Similarly, changes to informed consent may impact sample management requirements, which should be factored into the risk assessment.

Sponsors must ensure that their risk projections are continuously updated to reflect any changes to the study protocol, sample management procedures, or informed consent. This requires close collaboration between the sponsor, sites, and labs, as well as a robust system for tracking and managing these updates.

Make Slope your partner in biospecimen risk management

Managing biospecimen risk is a complex and ongoing process that requires vigilance, foresight, and the right resources. Many sponsors find themselves scrambling to address issues that could have been prevented with a more proactive approach.

Slope’s lab-agnostic and vendor-agnostic software, Biospecimen360™, is designed to be an integral part of your risk management strategy. Our software helps prevent the most common and serious sampling compliance risks from impacting your study while activities are still being performed. With real-time visibility into sample management activities, Biospecimen360™ provides immediate insights into potential non-compliance or issues with sample collection, processing, shipment, receipt, and storage. By identifying and addressing these risks in real time, you can ensure that critical samples are managed according to study requirements, protecting the integrity of your study data.

In addition, Slope's offers more than software; we also offer proactive operational support to identify and mitigate risks as your study progresses. Our team works alongside yours to develop robust workflows for sample collection, shipment, and metadata management, complete with customized risk management plans. And as your study evolves — whether through protocol amendments, changes to sample management procedures, or other factors — Slope ensures that your risk management strategies are continuously updated to reflect new challenges.

By integrating Biospecimen360™ and Slope’s services into your risk management strategy, you gain powerful resources that not only prevent potential sampling errors, but also enhance your overall study quality, reduce delays, and minimize patient burden. Don't wait for problems to arise — take control of your biospecimen operations with Slope, and ensure that your study stays on track from start to finish.

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