Barcodes & GS1: Unification and Transformation of the Clinical Trial Supply Chain

Aztecs, Stripes, & Matrices: The Barcode Revolution

Barcodes are everywhere— on your plane ticket, the eggs you buy, and menus you browse. Their convenience, safety, and efficiency have transformed daily life and global operations. Fun fact: the first barcode concept was sketched in the sand on Miami Beach in 1948. Launching in the food industry in the 1970s to streamline grocery checkout, today, barcodes are the backbone of modern supply chains and healthcare, where they ensure product authenticity and patient safety.

Barcodes in Healthcare

Barcoding technology is now integral to healthcare. From patient wristbands to medication administration, barcodes verify the “five rights” (right patient, drug, dose, route, and time), track supplies, and optimize inventory. In the lab, barcoded samples ensure accurate tracking from collection to analysis. Barcodes also enable seamless data integration across platforms, reducing manual entry and errors.

While barcoding initiatives drove best practice in healthcare facilities, growing concerns about the integrity of the U.S. pharmaceutical supply chain from incidents of counterfeit, stolen, or contaminated drugs highlighted fragmented regulations and limited unification. 

The DSCSA: Raising the Bar for Drug Security

Introduce the Drug Supply Chain Security Act (DSCSA), a landmark regulation enacted in 2015 designed to enhance the safety and security of the U.S. pharmaceutical supply chain. Segregated into 10-year implementation time, it mandates electronic, interoperable systems to identify and trace prescription drugs, improving the detection and removal of counterfeit or unsafe drugs.

Key DSCSA Provisions:

• Product Traceability: Every drug must be tracked from manufacturer to patient, using unique product identifiers and electronic transaction records.
• Drug Accountability: Rigorous record-keeping ensures every dose is accounted for, throughout supply chain to patient
• Data Integrity: Electronic systems enhance reliability and accuracy of data exchanged, as the drug product moves throughout the supply chain.

With a clear deliverable of interoperability throughout the supply chain, the FDA ruling supported standardization of electronic data flow – so everyone speaks the same language. While not required, the ruling cited supporting the EPCIS standard, developed by GS1 for standard data exchange.

Data exchange is two-fold. It’s the accompanying transactional electronic messaging, and the physical product movement – Back to Barcodes. The barcodes must be standardized to ensure interoperability across the pharmaceutical supply chain, especially for electronic data exchange and traceability.  Imagine, if the barcodes couldn’t talk to each other, that means an isolated scanner and possibly program for every drug coming into your practice.

While conceptually simple, the practical and logistical measures of meeting this call-to-action for standardization across the entire pharmaceutical supply chain presents tremendous challenges. But as commercial industry struggles to meet the FDA-mandated DSCSA requirements for commercial drugs, where does this leave investigational drugs? 

While exempt from DSCSA, investigational drugs are already subject to high levels of traceability and accountability…but rarely through barcodes or electronic messaging.   Within this ultra-controlled, niche environment, not only is traceability and accountability crucial, pioneering a standard barcode and electronic message seems intuitively practical.

As all members within the supply chain, from manufacturers to suppliers to hospitals and pharmacies seek alignment and collaboration, understanding the recommended GS1 standards is critical. 

GS1 Standards: The Global Language of Supply Chain

GS1 standards are internationally recognized guidelines for identifying, capturing, and sharing information about products, locations, and assets.

GS1 standards started and extended beyond healthcare. In retail, they streamline inventory and recalls; in food service, they boost safety and traceability from farm to table; and in logistics, they optimize shipment tracking and data synchronization flow. Across industries, adoption of the global GS1 standard ensures transparency and efficiency throughout global supply chains.

With supply chains adapting to updated regulations like DSCSA and seeking enhanced management and standardization, GS1 offers a framework and resources for implementing established practices.

Key GS1 Components:

• GTIN (Global Trade Item Number): Uniquely identifies each product, based upon manufacturer, product, and a check-digit.  The GTIN can be amended with additional product details to meet requirements, such as NDC, serial number, lot/batch number, and expiration date.       
• GLN (Global Location Number): Unique identifier for physical locations or legal entities (such as manufacturers, distribution warehouses, hospitals, or pharmacies) within the GS1 system.
• EDI (Electronic Data Interchange): Electronic message exchange of business documents (like purchase orders, shipping notices, invoices) in a standardized format between organizations.

Utilizing the 2D Matrix format, the barcode on a drug will contain the core elements to identify the product down to the package level: the Product Identifier (a GTIN with embedded National Drug Code (NDC), serial number, lot/batch number, and expiration date). GS1 barcodes also require an associated Human Readable Interpretation (HRI), which refers to characters printed above, below or alongside barcode. Not only does the HRI provide a downtime option when barcoded data must be manually interpreted or processed, it also allows industry to create consistent packaging designs across countries.  Using GS1’s specifications for EDI messages, standardized communication between supply chain partners allows for full product traceability. In this electronic messaging exchange, the GLN provides the identity of the sender, receiver, and other relevant locations. As the physical product moves throughout the supply chain, barcode scanning verifies the product accompanying EDI messages.

GS1 in Clinical Trials

The management of investigational drugs is inherently challenging due to limited regulations and guidance; from labeling, to packaging, and controlled supply. The adoption and alignment with GS1 standards can offer stringent control, accountability, and documentation essential for clinical trials. In the absence of regulatory enforcement, current barcodes on investigational products remain unstandardized, as manufacturers employ proprietary identifiers and messaging formats that are not universally readable throughout the supply chain. This lack of standardization results in inefficiencies, the creation of data silos, and a heightened risk of errors.

Seeking alignment and championing standardization, in 2024, Myonex, a Creapharm subsidiary, demonstrated the successful transition from proprietary 2D barcodes to GS1 DataMatrix on investigational products. Specializing in packaging, logistics, and supply chain management, Myonex’s pioneering of GS1 standards sets an example for industry companies, showcasing the feasibility of transitioning to a global standard in support of unified initiatives that improve clinical trial operations and bridge gaps between sponsors and sites.

Recently, a pilot study showed the feasibility of end-to-end integration between IRT and pharmacy management platforms using GS1 compliant barcodes and EDI standardized messages. This suggests impactful results of streamlined efficiencies, improved data accuracy, and reduced manual entry and transcription errors.

Future Outlook

The implementation of GS1 standards within clinical trial supply chains represents a significant advancement in promoting transparency, efficiency, and safety. Recent pilot projects have demonstrated that adopting these global standards is both feasible and beneficial for all parties involved. Enhancing awareness, facilitating knowledge exchange, and advocating for the adoption of GS1 standards encourage collaboration and foster continued innovation in clinical research.

References

GS1 US. (n.d.). Implementing GS1 Standards to meet DSCSA Guidelines. GS1 US. Retrieved September 30, 2025, from https://www.gs1us.org/industries-and-insights/by-industry/healthcare/standards-in-use/pharmaceutical/dscsa-implementation-guidelines

GS1. (2024). Introducing GS1 standards to the clinical trial supply chain at Creapharm, a Myonex company. In GS1 Healthcare Case Studies 2023-2024 (France) (pp. 60–65).