Sample management is a term that can have varying definitions depending on who you're talking to and their involvement in the sample journey. Sponsors, CROs, clinical research sites, and labs each have their own unique perspectives on what sample management means to them, as it often reflects their specific role and level of visibility into the overall process.
For the purposes of this blog, we are defining sample management as the process of collecting, processing, storing, shipping, tracking, analyzing, and receiving results for biological samples from patients for the advancement of clinical trials.
The sample journey is the path, or workflow, the biological sample takes from collection through receiving results, across all actions, locations, and stakeholders. There are many possible paths a sample can take depending on the complexity and requirements of a study. Typically, this journey looks more like a spider web than a straightforward process.
How does this impact the industry's view on sample management? As we stated above, if you are having a conversation with a clinical research site, a lab, or a sponsor or CRO, you'll likely hear different challenges, different levels of visibility, and different ideas of what it means to have visibility into or full traceability of samples. Also, the different stakeholders will place a varying level of importance on the steps of the sample management process depending on their role within the process.
Let us explain.
The sample journey truly begins at the clinical research site, as it is their job to ensure they have the right supplies, collect the sample from the patient, process the sample, store it, package it to protect its integrity and ship it to the lab. Their main priority is patient care, and to protect the integrity of every sample, and their successful completion enables them to be reimbursed for both the assessments and the visits. Once the samples leave the site, there is a blind spot in traceability.
For labs, sample management begins when they receive a sample at their lab. The majority of labs don’t know what samples are coming, or when, until it arrives on their doorstep. The labs could try to obtain courier information from a site and track the samples manually, but typically that is not something that is done on a regular basis.
Labs either process the samples or store them in a biorepository, or could even send it along to another lab. After processing, the labs archive the results in their own LIMS system and send the results to the sponsor, CRO, and/or clinical research site.
For sponsors, sample management often begins when result reports for samples are received back from a lab. Understanding the chain of custody may only become important when there is a problem with a sample, and it becomes necessary to track it down. In early-phase studies, sample management is crucial for ensuring that the necessary data is obtained to make decisions on drug safety and efficacy. The specimen data importance is typically driven by whether or not the sponsor has the information needed to continue developing that drug such as in the case of dose-limiting-toxicities or dose escalation. There are times where even the smallest number of unavailable samples can hold up a program. In later-phase studies, losing a few samples may not have a statistically significant effect on the study, but the burden of manually reconciling all samples and any issues can be resource-intensive.
CROs are responsible for managing specimens on behalf of the sponsor to ensure they deliver the required data. They may default to act like the sponsor and follow their SOPs and sponsor's requirements for specimen management, which may vary across different CROs. Depending on the contracted duties, they may manage the lab or work on intermediate steps in the sample management process. Ultimately, they are responsible for ensuring the sites follow sampling instructions including getting the sample to the lab. In addition, CROs ensure the results reach the sponsor.
As you can see, each stakeholder in the sample journey has a different lens for sample management due to their current level of visibility into the process. Not one stakeholder has true oversight or traceability of the entire sample journey from collection all the way through receiving the results.
We’ve developed a platform that enables sponsors, CROs, clinical research sites, and labs with full end-to-end traceability along the entire lifecycle of a sample - across all the workflows mentioned above. This includes while samples are in transit which is considered a blind spot to all stakeholders along the journey, as well as all the hops to various labs the sample may take before its data reaches the sponsor.
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