Executive Insights

Reshaping Clinical Trial Traceability: A Shared Language for a Smarter and Safer Supply Chain

As clinical trials grow in complexity, global reach, and regulatory scrutiny, traceability has become a non-negotiable pillar of clinical supply chain management. It’s no longer just about printing a label – it’s about ensuring that every investigational product is accurately identified, securely handled, and reliably tracked, from manufacture to administration at clinical sites.

In this context, traceability is more than a compliance requirement; it’s the enabler of quality, safety, and operational continuity in clinical research.

Why a Common Language Is Urgently Needed

Despite growing expectations from regulators and sponsors alike, many organizations still rely on internal identifiers or fragmented, disparate systems. This lack of standardization creates inefficiencies, delays, and unnecessary risks.

“Clinical supply chains are becoming more interconnected than ever. Without a shared framework for product identification, we cannot ensure consistency across partners, geographies, and platforms. That’s where traceability standards come in.”

Iben Vorre Fumex, VP Global Quality at Myonex

GS1: A Global Standard for a Global Challenge

Industry stakeholders are increasingly turning to GS1, a global, neutral non-profit organization to address the systemic challenges of standardization. GS1 developed the most widely used supply chain standards across multiple sectors, including healthcare and life sciences, to enable the encoding of essential product data.

In clinical trials, the GS1 DataMatrix is a compact barcode that allows product ID, batch, expiry date and protocol-specific identifier to be embedded, scanned reliably at every step of the chain and shared seamlessly across systems, such as packaging operations, IRT, depots, and trial sites. The use of this standard reduces the risk of errors and improves data integrity.

GS1 barcoding systems are endorsed by the FDA, EMA, and other health authorities to enhance traceability, improve safety, and support regulatory compliance.

Leading the Change – From Vision to Implementation

Expert Nicolas Le Rudulier, Global Partnerships Manager, has been a key contributor to GS1’s dedicated working group on clinical trials. His mission is to help shape a standard that’s not only regulatory-compliant but practical and scalable for real-world clinical operations.

In the podcast, “That One Barcode That Changed Clinical Trial Supply Chains”, and After Show conversation with Nicolas Le Rudulier from Myonex, Nicolas states:

“Reliable identification isn’t just about logistics – it’s a foundation for innovation and clinical research.”

As an example, this GS1 datamatrix enclosing reliable data opens doors to new interactions between sponsors and healthcare providers and patients, through the GS1 Digital Link.

A Connected Ecosystem, A Safer Future

Implementing GS1 standards means more than modernizing internal tools. It’s about enabling true interoperability – with sponsors, CROs, IRT providers, depots, and clinical sites for smoother operations and safer outcomes.

When every unit is traceable, communication becomes easier, timelines shorten, and patient safety improves.

What Sponsors and CROs stand to gain

Adopting GS1 standards brings measurable benefits for trial sponsors and clinical partners:

Data reliability and improved end-to-end traceability
Manual errors reduced by removing data re-entry
Seamless data exchange across IRT and other systems
Simplified study management at sites, freeing up capacity to handle more trials
Improved visibility and accountability across the supply chain

Understanding the operational impact of GS1 implementation is key for any organization considering the shift.

Read the case study

Looking Ahead: From Traceability to Trust

The traceability conversation is not just about technology – it’s about building trust. Ensuring every unit of investigational product can be uniquely identified and safely delivered, anywhere in the world, is essential to protecting patients and maintaining the integrity of clinical research.

As Iben Vorre Fumex, VP Global Quality at Myonex, concludes:

“When you embed traceability into your operations, you’re not just meeting standards- you’re reinforcing confidence. Confidence from regulators, from investigators, and ultimately, from patients.”