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Clinical Trials

With the GS1 Clinical Trial Application Standard, you get a global and harmonised way of identifying investigational products in clinical trials.

This makes the supply chain more efficient and everyday processes simpler for both manufacturers and end users.

The GS1 Clinical Trial Application Standard provides secure and efficient identification

Correct identification of investigational products is crucial in clinical trials—both for patient safety and for the smooth handling of the products.

The GS1 Clinical Trial Application Standard er en global GS1-standard, der sikrer korrekt identifikation og mærkning med scanbare stregkoder af forsøgsprodukter. Standarden er udviklet med repræsentanter fra virksomheder og kliniske forsøgssteder med fokus på at gøre arbejdet for sponsorer og investigatorer nemmere.

The standard also includes a necessary guideline  on how to efficiently exchange electronic data (EDI) about the investigational product. EDI ensures that your orders are processed automatically—saving time and resources while avoiding data entry errors.

Illustration viser 110 sponsorer og 57 kliniske forsøgsorganisationer har hjulpet med udvikling af en standard

Global standards make everyday work easier

Standards are already widely used for commercially marketed products. All products entering the supply chain are labelled with a 2D barcode and the product’s globally unique identification number. When all manufacturers follow the same standard, processes become consistent, easier to manage, and simpler for end users to handle.

Harmonising and applying the GS1 standard to clinical trial products can bring many benefits. It is a global standard that can be used worldwide.

Get started with 2D barcodes

Here you can see a clinical trial product labelled with a GS1-datamatrix.

Are you ready to begin the process of implementing a global standard for the labelling of investigational products in clinical trials?

If you would like to start the process or learn more about the standard, please contact us at

Illustration af firkantet pakke med 2D stregkode samt batch nummer, produkt id printet på

Identification of experimental products

Identification of investigational products is important, and GS1 has developed a global standard in collaboration with industry and clinicians that can be used to identify clinical trial products.

Watch this short video on the identification of investigational products, which explains how the standard was developed and the benefits it provides.

Electronic Data Exchange (EDI) in Clinical Trials

Manual registrations are time-consuming and increase the risk of errors.

With electronic data interchange (EDI), you achieve automation, allowing orders to be processed automatically and eliminating the need for manual data entry.

See for yourself how electronic data exchange in clinical trials can create value for you in this short video.

Benefits of Using GS1 Standards in Clinical Trials

Benefits for Sponsors

  • Faster data collection
  • Full traceability throughout the supply chain
  • Fewer transcription errors
  • Less time spent verifying and validating data

Benefits for Investigator Sites

  • Saves time
  • Improves inventory management
  • Limits internal relabeling and transcriptions
  • Easy-to-use processes that use barcodes

Benefits for patients

  • Adds increased security throughout the supply chain for patients themselves
  • Ensuring that the right product reaches the right patient
  • Fewer errors and safer handling

Stay up to date on legislation, GS1 standards and more in clinical trials and healthcare in general

Help and advice

If you have questions about how to use our GS1 standards, you can receive help and guidance every day.

We are ready to guide you smoothly through the process.

Send us an email

Then we will answer you as soon as possible:

sundhed@gs1.dk

Anne Marie Lei
Head of Public & Healthcare / Public Affairs
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+45 39 16 90 13
Jesper Kervin Franke
Senior Healthcare and Standard Specialist
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+45 39 16 90 02
Camilla Aabye Jensen
Senior Healthcare Specialist
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+45 33 60 37 76