The Tip of the Iceberg: Looking Below the Surface to Track Samples at the Site

Imagine you’re navigating the icy waters of the Arctic. You spot an iceberg and steer clear, aware that what you see above water is just a small fraction of its total size. The real risk lies beneath the surface, where the majority of the iceberg remains hidden from view. 

Similarly, clinical trial sponsors only see the tip of the iceberg when it comes to sample management activities at research sites. But unlike a real-life iceberg, which should be avoided at all costs, sample-related processes and their associated risks should be brought to light and addressed head on.

Effective sample management is critical to study success; after all, patient samples yield primary and secondary endpoints that demonstrate the safety and efficacy of a study drug. Sponsors typically have access to the final results and data once samples reach the lab, analysis is complete, and reconciliation has been performed. This is the visible tip of the iceberg. 

However, sponsors frequently face significant gaps in visibility to behind-the-scenes activities related to sample collection, processing, storage, and shipping. Just like an iceberg, the most crucial parts of sample management are often hidden beneath the surface. 

What risks are studies exposed to when sponsors don’t have visibility to sample tracking data at their sites?

Without the ability to scrutinize sample management procedures that are being performed by site personnel, sponsors may be vulnerable to several risks that could sink their studies, including:

• Compromised sample integrity: Without visibility to site activity, sponsors cannot ensure that samples are being collected and handled per protocol and lab manual specifications. Mishandling during collection, processing, storage, or shipping can degrade sample quality, and these compromised samples can lead to testing cancellations or unreliable data — potentially invalidating lab results and requiring costly re-collection efforts.
• Regulatory non-compliance: Sponsors and sites must comply with stringent regulatory standards for sample handling and data integrity. Lack of oversight increases the risk of non-compliance, resulting in deviations and study delays.
• Data inconsistencies and errors: Inadequate tracking and management can lead to data inconsistencies and errors, such as missed collections, misplacement of samples, or data entry mistakes. Data errors can hinder analysis and reporting, necessitating reconciliation or even causing trial failure.
• Delayed timelines: Without real-time insights into sample management activities, sponsors cannot identify and address delays in the collection, processing, or shipment of samples. Delays can prolong trial timelines, increase costs, and postpone critical decision-making.
• Inability to identify site performance issues: Sponsors miss opportunities to monitor site performance and identify sites that may be underperforming or encountering specific challenges in sample management. Poor site performance can go unnoticed, leading to overall trial inefficiencies and impacting the quality and speed of the trial.
• Increased costs: Lack of visibility can lead to unforeseen issues that require additional corrective actions, such as re-collecting samples, re-conducting tests, or extending study milestones. These corrective measures increase the overall cost of the clinical trial, straining financial resources.
• Difficulty in risk management: Without comprehensive oversight, sponsors cannot proactively identify and mitigate risks associated with specific sample collections, visits, patients, and sites. Unmanaged risks can lead to significant trial disruptions, affecting the ability to achieve trial objectives and milestones.
• Loss of competitive edge: Inefficiencies and delays due to poor visibility can slow down the trial process compared to competitors who might have better sample management systems in place. Slower trials mean delayed product development and market entry, giving competitors a potential head start.
• Erosion of stakeholder trust: Poor sample management and resulting issues can damage the trust of stakeholders — including investors, regulatory bodies, and trial participants. Loss of trust can affect future funding, regulatory relationships, and patient recruitment for future trials.

These risks — which can all stem from lapses in sample management processes at the site — can jeopardize the sample journey in the same way that an iceberg can jeopardize the journey of a sea vessel. 

Why is it important to have full visibility to site sample management activity?

Just as navigating safely through iceberg-filled waters requires an understanding of what lies beneath the surface, ensuring the success of a clinical trial requires full visibility to all aspects of sample management. Sponsors who only see final data outputs may miss out on identifying site performance issues, or trends that could indicate larger problems.

Having visibility to site activities enables sponsors to perform the following actions or make the following decisions:

• Proactive issue identification: Visibility to sample management activities allows sponsors to detect and address problems early, such as protocol deviations or delays in processing.
• Trend analysis: Understanding patterns in sample handling and management helps sponsors optimize processes, protocols, and improve site performance.
• Quality assurance: Continuous oversight ensures that samples are collected, processed, stored, and shipped in compliance with regulatory standards, thereby maximizing data integrity.

The iceberg of sample management highlights the critical need for sponsors to see beyond the surface. By leveraging advanced sample tracking and management solutions, sponsors can gain the visibility they need to successfully navigate the complexities of clinical trial execution. Just like navigating an iceberg, having a clear view of what lies beneath ensures more effective outcomes.

What activities should sponsors have visibility to at their research sites?

We’ve established that having visibility to sample management activities at research sites is critical for sponsors in order to reduce risk and optimize study outcomes through actionable insight; but what sample management activities should sponsors be keeping tabs on?

Sample collection

Every sample’s journey starts with collection. At this step, sites may simply forget to collect a required sample, which could be easily missed for a number of reasons — including a complex schedule of assessments; cohort- or population-specific collections; amendments; and more. Sponsors should have visibility at this step to ensure that all expected sample collections are actually being performed.

Sample processing

Samples may also need to undergo processing at a site — including centrifugation, aliquoting, fixation, and more. Proper processing is vital to ensuring that samples remain viable and can be analyzed appropriately at downstream testing labs. Sponsors should be aware of who is processing samples and when, so that any missteps can be promptly addressed. 

Sample storage

Samples may be stored at a site before shipment for any number of reasons — including batch shipping and sample-specific processing requirements that may take hours or days to complete. Unfortunately, it’s common for sites to forget about samples on site or to lose them altogether. Being able to monitor what samples are being stored on site for a specific study allows sponsors to ensure that their samples are being stored properly in an identifiable location and subsequently shipped.

Sample shipping

Samples are perhaps at the greatest risk when they are in transit. Sponsors should have automatic access to sample tracking numbers, as well as awareness of when a sample has shipped. This allows sponsors to monitor their samples prior to arrival at a lab, reducing the reliance on manual trackers and delayed access to tracking information. 

Slope offers workflows for sites that enable sample tracking of site-specific sample management activities

Sample tracking shouldn’t feel like blindly approaching an iceberg. Slope’s Biospecimen360™ software orchestrates the entire biospecimen lifecycle — from lab kit to final destination at a lab or biorepository. Our software turns static lab manuals into guided workflows that facilitate sample collection, processing, storage, and shipping for site staff; this not only maximizes site compliance with sample management procedures, but it also surfaces real-time sample metadata and chain of custody data for sponsors, labs, and other study stakeholders who need visibility into site-specific sample management activities.

To learn more about how Biospecimen360™ can support your end-to-end sample tracking solution, click here to request a demo.