The Procurement Paradox: Why Biospecimen Demand Outpaces Quality Control

By Zana Sljukic, Quality Assurance Associate at Reference Medicine

Precision medicine has reshaped oncology research in powerful ways. This shift isn’t incremental — it’s foundational. Biospecimen demand is rising not simply because research is expanding, but because it’s becoming more precise.

Today’s most innovative therapies are mutation-specific, biomarker-driven, and population-sensitive. A treatment may hinge on access to specimens that meet exact molecular and clinical criteria. As science narrows its focus, eligibility requirements follow suit. What was once a request for “breast cancer tissue” can now involve highly specific mutation profiles, defined treatment histories, tightly controlled ischemia times, and documented demographic data.

Layer in diversity expectations, regulatory scrutiny, and increased competition for limited material, and the imbalance becomes clear: demand is accelerating, but oversight systems are struggling to keep pace.

This is the procurement paradox.

Demand Is Scaling Faster Than Governance

Historically, procurement systems were designed for access and volume. The goal was to move specimens efficiently from clinical settings to researchers. For broader research questions, that model worked.

But today, it’s not enough to source samples. We have to source defensible samples.

Modern assays and AI-driven analytics amplify even small inconsistencies. A subtle variation in tissue handling or a missing metadata field can influence downstream analysis in ways that weren’t previously detectable. As science has become more exacting, governance must evolve alongside it.

When documentation relies too heavily on institutional trust or summary reporting, variability can slip through unnoticed. And in precision research, unnoticed variability isn’t minor — it’s consequential.

Quality Breaks Early — and Quietly

Most quality breakdowns don’t happen in dramatic fashion. They happen early and quietly, during the pre-analytic phase.

A delay in fixation. A gap in temperature monitoring. Inconsistent processing timelines. These moments may seem operational, but they directly affect biological integrity. RNA quality can decline. Protein expression can shift. Blood analytes can fluctuate. The impact may not be visible at receipt — but it often surfaces later, when results don’t replicate as expected.

These challenges are rarely the result of negligence. Clinical environments are, appropriately, focused on patient care. Without systems that proactively capture pre-analytic data and environmental controls, variability becomes embedded in the specimen long before it reaches a lab.

The Hidden Risk of Multi-Distributor Circulation

Scarcity introduces another layer of complexity. In high-demand areas — particularly rare mutations or narrowly defined patient populations — the same sample may pass through multiple sellers before reaching a researcher. 

Each transfer adds friction: potential relabeling errors, gaps in provenance, incomplete documentation, or unclear consent boundaries. Chain of custody can become harder to verify. Duplicate material may unintentionally enter research cohorts. Diversity metrics may be unintentionally skewed if limited population pools are repeatedly recirculated.

These aren’t hypothetical concerns. They are natural consequences of a supply chain optimized for volume and availability rather than traceability. And every additional handoff increases scientific and ethical uncertainty.

Consent Is Becoming Operational

Consent has evolved beyond a static form. It’s now an active responsibility.

We owe donors clarity around how their specimens will be used, especially when it comes to secondary research, data sharing, and commercialization. That means consent scope must be clearly documented, version-controlled, and honored throughout downstream distribution.

When provenance is fragmented, verifying consent becomes complicated. Even if a repository didn’t control the initial collection, it shares responsibility for ensuring that distribution aligns with what donors agreed to.

In a research landscape where public trust matters more than ever, ethical governance isn’t just compliance — it’s a differentiator.

Traceability Must Become Infrastructure

If the procurement paradox is rooted in the traditional business model of volume and access, we must evolve that model to meet today’s needs.

Quality cannot depend solely on individual vigilance. It must be built into systems. Digital chain-of-custody records, consistent identifiers that follow a specimen across institutions, integrated environmental monitoring, and robust laboratory information management systems should be standard — not optional.

A specimen’s history should be clear, continuous, and defensible. Donor consent should be explicit. Time-stamped custody documentation should travel with the material. Environmental data should be captured proactively, not reconstructed later. Traceability should be operational, not aspirational.

Access and Volume Versus Quality

At the heart of the procurement paradox is an incentive challenge. The market rewards capacity and availability, and suppliers are compensated accordingly. Meanwhile, investments in traceability, documentation, and governance increase operational cost — yet the market doesn’t consistently reward that added rigor.

When availability is prioritized without equal emphasis on traceability, long-term risk grows. Irreproducible findings, regulatory scrutiny, and lost research time ultimately slow innovation more than thoughtful governance ever could.

As AI and advanced analytics become more embedded in research, this tension will intensify. Sponsors won’t just ask, “Do you have it?” They’ll increasingly ask, “Can you prove it?”

We’re already seeing the early signs of market evolution. Exploratory discovery may tolerate variability. Translational research, AI validation, and regulatory submissions will not. Biospecimens are moving from commodity inputs to research assets that must withstand audit-level scrutiny.

A Call to Put Quality First

The procurement paradox isn’t simply about scarcity. It’s about stewardship.

Precision medicine depends not just on access, but on integrity. Researchers, sponsors, and biorepositories all have a role in realigning incentives so that quality is explicitly valued. Procurement agreements should reward complete metadata and verified pre-analytic documentation. Governance maturity should be recognized as a strategic advantage. Long-term partnerships should replace purely transactional sourcing.

Investing in structural traceability and consent governance doesn’t slow progress — it protects it. It reduces irreproducibility, strengthens donor trust, and ensures that advanced analytics produce insights that are reliable and defensible.

Demand will continue to rise. The question is whether procurement systems will rise with it.

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