Why Every Biotech Deserves a Biospecimen Manager

“So, where are we with the kidney biopsy results?” the study lead asked, her tone sharp and impatient. The call went silent. “We’ve got a board meeting in two weeks, and I’m certain this is on the agenda.” The tension in her voice was unmistakable.

“Well,” the CTM started hesitantly, “our CRAs told us all the samples were shipped to the resulting lab…”

If you’ve been a part of a study team in a biotech, you’ve probably heard conversations like this. The awkward silence. The scramble for answers. And at the heart of it? A gap in responsibility. There is a participant. There is a site visit. There is a protocol mandate to collect a biosample. Then what? That sample needs to be collected, processed, shipped, and analyzed. Yet, too often, these tasks are handed off to random study team members or CRO staff who are already overloaded and, frankly, not trained for the job. The result? A patchwork process held together by sheer willpower - and luck.

Some biopharma companies have wised up and created biospecimen operations roles. The best ones are well-integrated and effective. Others? They’re flailing like ships without a compass.

Here’s the bottom line:

·         Biospecimen management is a stand-alone function.

·         It’s a highly specialized role that requires the right expertise.

·         And it’s inseparable from the success of any study involving human samples.

Let’s dive in.

The Why

I used to think that managing biospecimens was just another task on the clinical trial checklist—until I witnessed the fallout from a mishandled sample. A bone marrow biopsy, invasive and painful for the patient, was collected and shipped without proper coordination. The lab, unaware of its arrival, lacked the personnel to process it immediately. By the time they did, the sample had fallen out of stability, rendering it useless. The patient had to endure a repeat procedure; the critical data cut was delayed for months; and the unplanned costs? Well, who cares about those, right?

This isn't an isolated incident. A 2023 survey revealed that 95% of biopharma professionals experienced increased trial budgets, timeline delays, or data quality concerns directly linked to biospecimen issues (1).

The complexity of clinical trials has surged, with an analysis of nearly 10,000 protocols showing a 70% increase in procedures and an 88% rise in data points collected. This escalation strains existing biospecimen management processes, often resulting in errors and inefficiencies (2).

Take trials requiring fresh biopsies, for instance. Their screening times are almost twice as long as trials without them. Why? Because biospecimen collection is complicated, and many sites simply don’t have the expertise to handle it well (3).

Then there’s the inconsistency. One site freezes samples at the wrong temperature; another mislabels them. Of course, we do have monstrous laboratory manuals that tend to spell out everything except for that most critical thing a given site needs to adjust to its workflows and avoid mistakes. Yet, mismanaged samples almost inevitably lead to unreliable data - jeopardizing biomarker analyses and, ultimately, the trial’s success.

When it comes to specialized or custom collection and processing, without someone who truly owns the process—someone trained to understand not just the "how" but the "why" behind these collections—you end up with botched samples that give you nothing usable in return.

The bottom line? Without a dedicated biospecimen function, trials face data errors, testing delays, and shipment issues that can throw everything off track. But when biospecimen management is done right, compliance improves, costs drop, and delays shrink. Patients benefit, and so do the teams running the trials. This means that establishing this role isn't just beneficial; it's essential for the success of modern clinical research.

What’s Needed

With all the love and enormous respect for CTMs, CRAs, and Logistics of the world, biospecimen management isn’t a job you can just hand to anyone and hope for the best.

Here’s the thing no one tells you: biospecimen management isn’t just about moving samples from Point A to Point B – although there is A LOT of that in the day-to-day excitement of the function. It’s about owning the entire lifecycle of those samples - from guiding the collection to ensuring samples are usable when they hit the lab.

To excel at biospecimen function, you must be fluent in biospecimen science, a real scientific field that dives deep into the nitty-gritty of sample handling, stability, and pre-analytical variables. You also need hands-on laboratory experience to understand how samples behave in real-world scenarios. A background in wet lab work? Non-negotiable! Without it, you’d miss the subtle but critical details that could make or break a biomarker assay. Understanding and navigating shipment logistics? You bet!

But it doesn’t stop there. Biospecimen management is as much about people as it is about science. You need project management chops to juggle vendors, timelines, and protocols. You need training skills to bring the site staff up to speed on complex collection and handling procedures. And you need people management skills - because at the end of the day, you’re coordinating across clinical teams, labs, and even external stakeholders.

The bottom line? Biospecimen management is a specialized function. It requires a unique blend of technical knowledge, operational expertise, and interpersonal skills. Without the proper training and preparation, even the most well-meaning professional will struggle to do the job justice.

With the shift toward personalized treatment of molecularly defined populations, more clinical trials rely on biomarker-driven approaches for identifying eligible patients or monitoring therapeutic responses. Why? A recent analysis of 9,704 development programs from 2011 to 2020 found that trials employing a preselection of biomarkers have a two-fold higher likelihood of approval, with a nearly 50% Phase 2 success rate (4).  The verdict is quite clear: Since the studies are not going to get simpler any time soon, we need to have a specialized, dedicated agency that oversees these biomarkers and actually knows what she is doing.

Think about this: how much smoother would clinical trials run if every biospecimen was collected, handled, and delivered perfectly every time? It’s not a pipe dream - it’s what happens when biospecimen management is treated as a critical, stand-alone function.

The Takeaway

The takeaway here is simple but urgent: the industry needs to formalize the role of biospecimen management. This isn’t just about creating a new title - it’s about defining expertise, setting standards, and providing the training necessary to support this role. When done right, biospecimen management becomes the linchpin of trial success, reducing delays, cutting costs, and ensuring the data needed to bring life-changing therapies to patients.

References

[1]          “Can Sample Management Processes Handle the New Tide of Clinical Research? Currently, No. · Slope Blog.” Accessed: Jan. 21, 2025. [Online]. Available: https://www.slopeclinical.com/blog/can-sample-management-processes-handle-the-new-tide-of-clinical-research-currently-no, https://www.slopeclinical.com/blog/can-sample-management-processes-handle-the-new-tide-of-clinical-research-currently-no

[2]          K. A. Getz and R. A. Campo, “Trends in clinical trial design complexity,” Nat. Rev. Drug Discov., vol. 16, no. 5, pp. 307–307, May 2017, doi: 10.1038/nrd.2017.65.

[3]          J. H. Cheng, J. W. Tiulim, S. Zhou, A. El-Khoueiry, and J. Nieva, “Mandatory Research Biopsy Requirements Delay Initiation of Clinical Trials,” Front. Oncol., vol. 9, p. 968, Oct. 2019, doi: 10.3389/fonc.2019.00968.

[4]          “How Biomarkers Impact Clinical Trial Study Start-up - PFM.” Accessed: Jan. 21, 2025. [Online]. Available: https://www.precisionformedicine.com/blog/how-biomarkers-impact-clinical-trial-study-start-up/