Having Trouble Tracking Down That Critical Sample? Here’s Why.

Imagine you are responsible for overseeing the management of all biospecimens collected across multiple clinical trials. Today, you received an urgent request from one of your colleagues: they need the current status of a specific tissue sample collected three weeks ago on a global trial because the sample is overdue for analysis. Without the lab data associated with this tissue, the patient can’t screen for the trial — and the low-enrolling study is at an even greater risk of not reaching critical milestones on time.

Immediately, your brain begins firing off several questions. How do you track down this sample? What data sources and tools can you use to facilitate your investigation? Are these data sources readily available and up-to-date? Has this data been QC’ed? How does the nature of managing tissue samples complicate your efforts?

As we will see, the answers to these questions highlight the limitations of traditional approaches to sample tracking.

Every day in clinical research, thousands — perhaps even millions — of patient samples are collected in support of primary and secondary endpoints. Given the foundational role that these samples play in generating precious data for clinical trials, many sponsors must invest in biospecimen operations to ensure the quality, compliance, and integrity of these samples and their associated data.

Unsurprisingly, biospecimen management is no small task. Each trial may be comprised of a complex network of sites, labs, CROs, and data vendors — all of whom play some role in collecting, processing, testing, storing, shipping, and/or reconciling patient samples across many sample types. Managing these complex sample workflows requires meticulous attention to several moving parts.

For this reason, tracking down a specific sample can be a daunting and time-consuming task without the right tools and resources. 

Manual tracking and fragmented data are the current norm in biospecimen operations

In many organizations, the process of tracking down a specific sample involves a combination of manual tracking methods — often using Excel spreadsheets and pulling data from various sources. 

Here is how your sample investigation might unfold:

Checking Shipment Information: Your first step is to look for the air waybill and tracking number to confirm the shipment details of the sample. This information is usually available immediately upon shipment, but may be buried in emails or stored in a separate system. If tracking information isn’t available, you are left with no choice but to follow up with the site. Unfortunately, most sponsors don’t have visibility to site activity prior to shipment.

Pulling Lab Data: Next, you turn your investigation to the lab where the sample was sent for processing. Oftentimes, lab data exists across several datasets, so you must run several reports to look at samples that are discrepant or on hold, sample processing data, and sample storage data. Unfortunately, this data is not always real-time and may take days or even weeks to be updated — especially in the case of patient tissue, which may need to undergo additional processing steps before it is tested. 

Reviewing EDC Data: You then turn to the Electronic Data Capture (EDC) system for additional information. EDC data is critical but is also not updated in real-time — often taking days, weeks, or months after sample collection to be accurate and complete.

Consolidating Data: With information being pulled from various sources at different cadences, you spend hours piecing together and cross-referencing the data. This process is prone to errors and inconsistencies, especially when relying on data that has not been officially QC’ed. 

Reporting to Stakeholders: Despite your best efforts, you are pressured to provide updates to study teams or leadership. Given the fragmented and delayed nature of the data, you may not have 100% confidence in the accuracy of your findings. This can lead to stress and uncertainty, as well as potential delays in the study timeline.

Limitations in traditional approaches to sample tracking highlight common pain points for biospecimen management

This scenario highlights several pain points faced by those in biospecimen operations:

• Inefficiency: The manual tracking process is time-consuming and labor-intensive, requiring you to pull data from multiple sources and manually reconcile discrepancies.
• Inaccuracy: The lack of real-time data and reliance on error-prone information increases the risk of errors and inconsistencies in the sample tracking process.
• Stress: The pressure to provide accurate and timely updates can be overwhelming, especially when you lack confidence in the data you have compiled.

Use Slope's Biospecimen360™ to track down important samples with ease

Given these challenges, it is clear that clinical trials are in need of a more efficient and reliable sample tracking solution. 

This is where Slope's biospecimen lifecycle software comes into play. Biospecimen360™ enables real-time access to high-quality sample metadata in a single platform, eliminating the need for manual tracking and data consolidation from disparate sources.

Biospecimen360™ streamlines sample tracking in the following ways:

• Centralized Data Platform: Our software provides a centralized platform where all sample metadata is stored and updated in real-time. This eliminates the need to pull information from multiple sources — saving your team a significant amount of time and effort.
• EDC and Lab Integrations: Our platform enables bi-directional integrations across various sources — allowing you to feed data to and from labs and EDC systems. This ensures that all relevant information about your samples is available in one place, reducing the risk of errors and discrepancies as data flows from one stakeholder to another.
• Real-Time Updates: With real-time access to sample metadata, you can track the status of any sample at any given moment. This ensures that you always have the most up-to-date and accurate information at your fingertips.
• Sample Guided Workflows: Automated workflows automatically capture sample metadata as sites perform sample management activities — giving sponsors visibility into site activity and minimizing the potential for human error.
• Enhanced Reporting: With accurate and real-time data, you can generate reliable reports quickly and easily, providing stakeholders with the information they need with confidence.

Sample tracking doesn’t have to entail manually pulling reports from different sources, sifting through emails, or maintaining an Excel spreadsheet. Contact us today to learn more about how Slope can help you revamp your biospecimen operations.