What the Biospecimen Management World Can Learn from EDC and ePRO

The world of clinical research has never been static. Over the last two decades, it has experienced seismic shifts — each sparked by necessity, accelerated by technology, and cemented by regulatory evolution. 

For example, think about how clinical trial data collection transformed with the advent of electronic data capture (EDC), or how patient-reported outcomes became more reliable and compliant with the rise of electronic patient-reported outcome (ePRO) tools. These were not just technological upgrades; they were paradigm shifts. And now, it’s biospecimen management’s turn.

Paradigm shifts are born from necessity

Paradigm shifts rarely emerge out of convenience; they arise out of necessity. In the past, paper-based case report forms (CRFs) were the norm, requiring manual data entry and cumbersome reconciliation. The inefficiencies were obvious, including increased error rates and significant logistical management. Then EDC systems came along, providing more structured data capture, centralizing oversight, and streamlining monitoring. The result? Higher data quality, faster study execution, and reduced risk.

A similar story played out with patient diaries. Handwritten logs were error-prone and difficult to track. The transition to ePRO systems brought vast improvements like timestamped entries, automated compliance monitoring, and less administrative burden — boosting both data integrity and patient engagement.

These shifts didn’t happen overnight, nor were they easy. But they became inevitable, not just because the technology existed, but because the stakes had become too high to ignore.

Biospecimens are now at a similar crossroads

Today, biospecimens are central to trial outcomes, biomarker discovery, randomization and treatment decisions, dose escalation, and much more. Yet the infrastructure supporting biospecimen operations — like requisition forms, sample trackers, and data reconciliation processes — has lagged behind. Paper forms, spreadsheets, and disjointed lab portals still dominate the landscape.

Why does this matter now more than ever? Because the risks are growing:

• Increased trial complexity is introducing new operational burdens across the biospecimen lifecycle.

• Manual requisition workflows and point solutions create fragmented processes, leading to data lag, visibility gaps, and reconciliation challenges.

• Siloed teams across sponsors, sites, labs, and CROs lack a shared source of truth for biospecimen activity.

• Most critically, ICH E6(R3) has formally recognized biospecimens as part of the essential clinical trial record.

ICH E6(R3): A catalyst for change

The newly released ICH E6(R3) guidance is not just a run-of-the-mill regulatory update; it’s also a recognition of biospecimen management as a core element of trial quality and compliance. 

Among the most notable implications:

• Sponsors are now expected to apply a risk-based approach to biospecimen operations, just as they do for other critical data and processes.

• Biospecimen documentation — from collection and chain of custody to processing and retention — is now part of the essential record.

• There are explicit sponsor requirements for tool validation and oversight.

These expectations reflect long-standing challenges that can no longer be overlooked. The message is clear: biospecimen management must evolve.

Why paradigm shifts require flexibility first

Change is hard — especially in a field as regulated, complex, and high-stakes as clinical research. Sites, labs, and sponsors have grown accustomed to their established workflows, and transitioning to new technologies or approaches can feel disruptive.

But successful paradigm shifts don’t require throwing everything out. They start with configurable, flexible solutions that meet stakeholders where they are, then help them evolve toward where they need to go. EDC systems didn’t demand a radical redesign of protocols; they adapted to them. ePRO systems didn’t change the importance of the patient voice; they simply captured it more effectively.

The same must now happen for biospecimens.

The future is coming for requisition forms

At the heart of biospecimen inefficiency lies a deceptively simple document: the requisition form. Despite being the starting point for sample workflows, requisitions are still managed through paper and lab-specific portals — none of which are built for dynamic trial operations.

What if requisition workflows could be digitized, standardized, and connected end-to-end across stakeholders? What if sponsors could gain streamlined visibility into sample activity, ensure compliance with ICH E6(R3), and finally eliminate the manual reconciliation headaches that have plagued trials for years?

That future is not only possible—it’s already underway.

Ready to see what’s next?

• Join us for our upcoming webinar on June 17th: “The Future of Requisition Forms”, where we’ll explore how technology can redefine biospecimen workflows from the ground up.

• Want a deeper dive? Download our interactive guide, “Requisition Workflows Reimagined,” to explore what modern biospecimen management looks like.

• Curious about how your current processes measure up? Take our free ICH E6(R3) Biospecimen Risk Self-Assessment and receive a high-level scorecard that evaluates your potential compliance risks and areas for improvement.

Paradigm shifts don’t happen all at once — but they begin when necessity meets opportunity. The inefficiencies and risks of traditional biospecimen management are no longer sustainable. With ICH E6(R3) raising the bar and technology finally catching up, the next shift in clinical research is already in motion. The only question is: will you lead the change, or be forced to catch up?