Does It Seem Like Your Samples Disappear into a Black Hole at the Lab? Here Are 4 Reasons Why.

If there’s one thing we can all agree on when it comes to running a clinical trial, it’s that time is of the essence — especially when delays impact patient outcomes. 

With that in mind, imagine you're supporting biospecimen operations on a critical trial, and a tissue sample from a potential participant has just been sent to the lab for screening. Days pass before you receive the tracking number, and even longer before you see any acknowledgment from the lab that the sample has been entered into their databases. With no visibility into what’s happening behind the scenes, you're left in the dark, unsure if the sample is being processed or if it’s stuck in a queue somewhere.

The lab's histology group needs to section the slides before sending them to pathology for review. Unfortunately, you have no way of easily figuring out if the slides have been cut, if there are queries delaying processing, or even if the sample is sufficient for testing. You’re left relying on a manual tracker, which isn’t updated in real time, prone to errors, and makes it nearly impossible to react swiftly if issues arise.

For sponsors, this lack of transparency into lab processes not only disrupts the flow of the trial, but can also have serious implications for patients who rely on lab results to start or continue treatment. Every day that passes without clear answers delays critical decisions and can compromise the trial's success.

So why can it feel like samples go into a black hole once they arrive at the lab? And what can sponsors do to improve their processes for tracking their time-sensitive samples once they have arrived at the lab? Here are 4 areas of your lab and biospecimen operations to consider.

1. The sample receipt bottleneck

Once your samples change hands from the site to the courier, their journey is far from over. The first stop is the lab, where samples must be accessioned into the lab’s database. Accessioning is a critical step that officially acknowledges the receipt of the sample and initiates the processing and testing phase. However, confirming sample receipt isn’t always straightforward.

Even though sample receipt can technically be monitored through tracking numbers and sample reports generated by the lab, there’s often a significant lag. It can take days before sponsors receive confirmation that a sample has been received and logged in a lab database, leaving them in a temporary state of uncertainty. This delay in information flow creates a bottleneck, as subsequent steps in the biospecimen lifecycle can’t commence until the sample is officially acknowledged by the lab.

2. The fog of lab processing

Even when a sample is confirmed as received, sponsors often find themselves in the dark about the next steps in the lab. Critical processing activities such as aliquoting and slide sectioning are essential to prepare the sample for testing. Yet, this part of the process remains difficult for sponsors to easily track.

Without visibility into these intermediate steps, sponsors are left guessing about the status of their samples. In the above example, the sponsor may be asking questions like, “Have the slides been sectioned yet? If so, how many? Are there any outstanding queries that could delay the process further?” This lack of transparency creates inefficiencies and introduces risks, as sponsors can’t address potential issues in real-time — leading to delays in patient care and study timelines.

3. The complication of lab queries

Lab queries add another layer of complexity to the biospecimen lifecycle. These queries can arise due to missing or incorrect sample metadata, insufficient sample quantity, or other sample-related issues. Until these queries are resolved, the sample may not be able to proceed to the next stage of processing or resulting. However, these issues are often not communicated promptly or clearly to the sponsor.

This lack of communication means that lab queries can cause significant delays, further complicating an already muddled process. Sponsors may not even be aware that a query exists until they notice a delay in the sample’s progress. By the time the query is resolved and the sample metadata updated, valuable time has already been lost.

4. Sample testing cancellations: a hidden hurdle

Sample testing can be canceled for a variety of reasons — stability issues, hemolysis, site or lab errors, and more. Unfortunately, sponsors often discover these cancellations too late. The process of accessing cancellation data is typically cumbersome, requiring sponsors to run separate reports or request updates manually.

This lack of integrated visibility creates a disjointed experience where sponsors must piece together information from various sources. The result is an inefficient, highly manual process that leaves sponsors vulnerable to missed deadlines and compromised data quality.

The need for enhanced visibility

Given these challenges, it’s clear that sponsors need more complete and quicker visibility into lab activities. The current state of affairs — where critical steps in the sample journey are either inaccessible or manually tracked across multiple reports — is no longer sufficient. To stay competitive and ensure the success of their trials, sponsors must have real-time insights into the entire biospecimen lifecycle.

This kind of transparency is not just a luxury; it's a necessity. With the ability to monitor each step of the process, sponsors can react quickly to any deviations, ensure timely decision-making, and ultimately, safeguard patient outcomes. But how can sponsors achieve this level of oversight in a fragmented and vendor-dependent ecosystem?

Regain control of your lab activity with Slope

Slope’s lab-agnostic and vendor-agnostic software, Biospecimen360™, offers a solution to these visibility challenges. Through bi-directional integrations with labs, Biospecimen360™ streamlines biospecimen operations. E-requisitions automatically share pertinent sample metadata with labs, accelerating the accessioning process and reducing the likelihood of queries. By enforcing guardrails for sample metadata capture at the site, the software minimizes the chances of errors that could delay sample processing and resulting.

Biospecimen360™ offers the ability to surface lab tracking information directly in the sponsor’s view of the sample journey within the software. This integration provides sponsors with real-time, comprehensive insights into the status of their samples — from their initial state as an empty container in a lab kit at the site, to their receipt, processing, and storage across various labs. With this level of transparency, sponsors gain peace of mind and can confidently navigate the complexities of their trials.

Slope’s professional services complement this software by offering lab vendor oversight from study startup to study closeout. Our experts will lead your routine lab meetings, manage your lab timelines, and thoroughly document meeting minutes to ensure that lab deliverables stay on track and that any quality events are promptly addressed. With Biospecimen360™ and Slope’s expert support, sponsors can finally break free from the lab black hole, regain control over their biospecimen lifecycle, and drive their trials toward success.

To learn more about how Slope can support your lab operations, click here to speak with an expert. In the meantime, check out our article on the importance of sample tracking across the biospecimen lifecycle.