Why Is It So Hard to Track Sample Shipments from Research Site to Lab?

When it comes to running a clinical trial, tracking sample shipments from research sites to various labs is a critical part of monitoring the biospecimen lifecycle; but as many of us know, executing on this is far easier said than done.

Think back to a time when you’ve had to urgently track samples from a critical patient visit. You scramble to get the tracking number, but you are relying on the site and CRO to send you the information. A day or two passes, and when you finally get the number, you realize the samples have been shipped to the wrong lab. By the time the error is discovered, it's too late to intervene. The samples, which have a short stability period, are no longer viable. To make matters worse, you’re left with no visibility into which samples were included in the shipment.

Suddenly, your study faces a critical delay. In a best case scenario, the patient agrees to have their samples recollected — but this requires a significant sacrifice from the patient, who may have to take additional time and effort to travel back to the clinic. Even then, the samples may be collected out of window, resulting in a protocol deviation that could bring additional scrutiny to the lab results. In a worst case scenario, the patient may be forced to drop from the trial — potentially depriving them of an opportunity to continue pursuing the treatment they need, while delaying the overall milestones for a trial that is already enrolling at a slow pace.

This nightmare situation is all too common in clinical trials. The journey of samples from the research site to the lab is fraught with gaps and inefficiencies. But why do these gaps exist, and what can sponsors do about it?

What process gaps impede successful sample shipments?

Traditional methods for preparing and tracking sample shipments put biospecimens at an increased risk of mishandling or delayed processing. But what exactly are these common industry practices, and how do they contribute to issues with sample management?

Manual processes and written instructions at sites

Many research sites still rely on manual processes and written instructions in the lab manual to prepare sample shipments. This antiquated approach increases the risk of accidental oversights — such as shipping samples to the wrong location, shipping on blackout dates (e.g., shipping on a Friday when a lab doesn’t accept weekend shipments), shipping samples later than required, shipping samples in the wrong condition (e.g., ambient instead of frozen), or shipping using the wrong courier. The complexity intensifies when sites manage shipments across multiple trials and sponsors, or even within a single trial where samples from the same patient visit may need to be shipped to different locations.

Furthermore, the reliance on written instructions means that any updates or changes to study requirements that impact sample management procedures might not be communicated effectively to the site staff. This can result in outdated instructions being followed, increasing the risk of non-compliance with the study requirements. 

Lack of visibility for sponsors

Sponsors often remain in the dark about sample statuses until labs acknowledge receipt. They lack real-time insights into what was collected, if and when it was shipped, and any potential issues during transit. This absence of visibility stems from both site errors—like shipping on blackout dates, or using incorrect conditions or couriers—and courier issues such as mishandling or weather delays.

This lack of visibility can be particularly problematic in trials involving critical or time-sensitive samples. Sponsors might not be aware of deviations from the expected sample shipment procedures, which can affect sample viability. Without timely information, sponsors cannot take corrective actions to mitigate the impact of these issues. This not only affects the quality of the samples, but can also delay the overall timeline of the study.

Moreover, in the absence of real-time tracking, sponsors are left to rely on retrospective data to investigate any issues that arise. For instance, if a sample is found to be non-viable after reaching the lab, the sponsor has to trace back the entire process to identify where things went wrong. This reactive approach is time-consuming and inefficient, highlighting the need for a more proactive tracking system.

Inefficient manual tracking

To bridge the visibility gap, sponsors might resort to manually tracking shipments; however, this method is riddled with inefficiencies. Sponsors often have to request tracking numbers from CRAs or sites, a process that can take days. By the time they receive this information, it’s often too late to address any issues. Additionally, tracking numbers don’t reveal site activities prior to shipment, leaving sponsors in the dark about what exactly is in the shipment or how samples were handled before they were picked up by the courier. Manually checking each tracking number on courier websites is also time-consuming and impractical, especially for large-scale trials. This administrative overhead diverts valuable resources from other critical aspects of the trial, such as patient recruitment and data analysis.

Slope makes sample shipment tracking easier than ever

Slope’s biospecimen lifecycle management software, Biospecimen360™, offers an all-encompassing solution to the most prevalent shipment tracking woes. Here’s how:

• Guiding sites through sample shipping: Biospecimen360™ guides research sites through the sample shipping process, significantly reducing the risk of errors. The software ensures that sites remember to ship samples, use the correct couriers, avoid blackout dates, and ship samples in the proper condition and shipper.
• Providing real-time visibility: Biospecimen360™ surfaces shipment tracking numbers in real time, providing sponsors with instant access to this crucial information. No more waiting for days or chasing down tracking numbers. This immediate visibility allows sponsors to monitor shipments and intervene swiftly if issues arise.
• Offering comprehensive overview of the sample journey: With Biospecimen360™, sponsors can see how samples were handled at the site, sample shipment details, and sample status details from the lab. This comprehensive oversight reduces the risk of delays, ensures sample viability, and enhances overall study efficiency.
• Giving sponsors peace of mind: With Biospecimen360™, sponsors gain peace of mind knowing their samples are managed correctly. Real-time visibility into the sample journey means sponsors can focus mitigation efforts where needed and reduce the time and effort required to track down specific samples. 

To learn more about how Slope and Biospecimen360™ can support sample tracking across the entire biospecimen lifecycle, click here to speak with an expert.