September 3, 2024

Is Your Strategy for Managing Lab-to-Lab Sample Shipments Jeopardizing Your Trial?

Imagine you’re managing a rare disease trial where every single patient sample counts. In this study, samples are first shipped to a central lab before being sent to a specialty lab for crucial testing. The strategy was designed to ease the burden on research sites, streamline the sample shipping process, and enable the consolidation of data across all of your labs. Everything should go smoothly, right?

But then, disaster strikes. A critical primary endpoint sample belonging to one of your patients vanishes into the void between labs. Days pass, and you’re left scrambling for answers. By the time the sample is finally located, it’s too late. The sample is out of stability for testing, and now you face a costly decision: Do you risk missing a key endpoint, or ask the patient to come back for a recollection, knowing full well the burden it imposes?

This scenario is all too familiar for many sponsors. The lack of visibility in lab-to-lab shipments is a ticking time bomb that can negatively impact your study if not properly managed.

The common risks of lab-to-lab shipments

Lab-to-lab shipments introduce a new level of complexity in clinical trials, where timing and accuracy are critical. Unfortunately, the lack of transparency in these shipments can lead to significant setbacks. Here’s how things can go wrong:

  • Delays due to lab queries: A simple error on a requisition form at the site level can trigger a cascade of problems downstream. The sample reaches the central lab, but a query arises — perhaps the req form was filled out incorrectly, or critical metadata is missing. The sample cannot be shipped to the specialty lab until the query is resolved. By the time the issue is brought to your attention days later, valuable time has already been lost. You manage to resolve the query after an additional day of going back and forth with the site and the site monitor, but the clock is ticking, and every day counts.
  • Transmission of requisition form errors: An error on a requisition form can cause more than just lab query delays — it can also propagate downstream, affecting the accuracy of data across multiple lab databases. For example, incorrect sample metadata can lead to faulty data analysis at the specialty lab, even after that data has passed through a central lab. These errors often require time-consuming and complex reconciliation efforts across different lab systems, potentially compromising the integrity of your study’s data analysis. 
  • Incompatible data sharing between labs: Labs use different systems and formats to share data, meaning that data from the central lab to the specialty lab may not seamlessly fit into the specialty lab’s database. As a result, critical sample metadata may be lost or misinterpreted when changing hands from one lab to another — causing delays, discrepancies, and the need for manual intervention. 
  • Tracking numbers in limbo: Once the query is resolved and the sample is finally shipped, you’re left waiting for a tracking number from the central lab. Days pass before you receive it. You’re now left in the dark, unable to pinpoint the exact location of the sample or when it will reach the specialty lab. This lack of visibility is unnerving, especially when every sample is critical to the success of your study.
  • Prolonged sample receipt confirmation: Even after the sample arrives at the specialty lab, the challenge doesn’t end. It can take days before the sample is acknowledged and received in the lab’s system. The sample report you pull from the lab portal shows nothing. The uncertainty lingers, making it difficult to plan next steps or prepare for data analysis. The anxiety intensifies as you wonder if the sample was mishandled or damaged during shipment.

Lab-to-lab transfer issues can have negative consequences

The result of these compounded issues? The sample finally arrives at the specialty lab but is deemed unusable. It’s out of stability for testing. Now, you’re faced with two painful options: Lose out on critical primary endpoint data, or ask the patient to return to the clinic for a recollection — a request that could strain the patient relationship and affect your study’s retention rate.

This nightmare scenario is a stark reminder of the importance of visibility in lab-to-lab shipments. Without it, sponsors are left vulnerable to delays, data quality issues, and potentially devastating trial outcomes.

Slope solves your most common issues with lab-to-lab shipments

At Slope, we understand the critical importance of visibility and control in the biospecimen lifecycle. That’s why our Biospecimen360™ software and professional services are designed to address the exact challenges sponsors face with lab-to-lab shipments.

1. Integrations for seamless visibility: Biospecimen360™ is lab-agnostic, offering seamless integrations with labs and shipping vendors. This means that your sample’s journey from site to central lab, and from central lab to specialty lab, is fully visible within our platform. Tracking numbers, shipment statuses, and sample metadata are shared in real-time, so you’re never left guessing about the location or status of a sample.

2. Proactive query resolution: Our software enforces guardrails for sample metadata collection at the site, ensuring that requisition forms are filled out correctly and consistently. This reduces the likelihood of queries arising at the central lab, preventing delays in lab-to-lab shipments. Issues are visible in the software, allowing for swift resolution before it causes significant delays.

3. Bi-directional lab data sharing: With Biospecimen360™, data flows both ways. Not only do labs transmit sample metadata to our system, but our platform also surfaces this information back to sponsors. This means you have real-time access to tracking information, sample statuses, and lab receipt confirmations. You can rest easy knowing that your sample is where it needs to be — and if it’s not, you’ll know immediately, giving you the power to act quickly.

4. Support for custom lab strategies: We recognize that no two studies are the same. Our Biospecimen Data and Operations team can work with you to select vendors and develop custom sample collection, shipment, and metadata workflows that fit the unique needs of your trial. Whether that means adjusting your lab strategy or implementing specific risk management plans, we’re here to ensure that your samples move smoothly through the lifecycle with minimal risk.

5. Lab oversight and support: From study startup to closeout, Slope’s experts provide oversight and support for your lab vendors. We hold regular meetings, manage timelines, and document every step of the process to ensure that lab deliverables remain on track. We use sample metadata in Slope in conjunction with lab data to ensure proper and efficient sample movement, as well as availability for testing.

The stakes are high in clinical trials, and the lack of visibility in lab-to-lab shipments can be a significant risk to your study’s success. But with Biospecimen360™ and Slope’s professional services, you can eliminate the guesswork, reduce discrepancies, and gain full transparency into the movement and status of your samples. 

Don’t let lab-to-lab shipments derail your trial. Speak with an expert at Slope to gain the visibility and control you need to keep your study on track.

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