The Global Language of Business
 

Enabling standarisation in the clinical trial supply chain

What if we all spoke the same language in clinical trials?

Global standards by the industry

The new global standards are the result of an industry-led working group:

110
Representatives
57
Clinical trials organisations
Chaired by CH
Victor Dupouy,
Pfizer and Sanofi
Pharmaceutical companies,
hospitals, IT solution providers,
contract research organisations

...for the industry

Manufacturer

Packaging site

Distribution centre

Clinical site

Subject

Applicable to
blinded and unblinded trials

Global Trade Item Number (GTIN)
for unambiguous identification of investigational product kits and their components

Global Location Numbers
for unambiguous identification of locations

Standardised GS1 XML messages to communicate about the location, status, availability and dispensing activity of investigational product kits and their components

Across-the-board benefits

 

Benefits for suppliers

  • Quicker data compiling
  • Full supply chain traceability enabled
  • Fewer transcription errors on the backend
  • Less time spent verifying and validating data
 

Benefits for clinical trials sites

  • Saves time
  • Improves inventory management
  • Limits need for internal re-labelling and transcriptions
  • Easy to adopt processes that leverage the barcodes
 

Benefits for patients

Adopting GS1 Standard adds an element of trust at all levels of the supply chain – a trust that ultimately extends to the patients themselves.

What the industry needs is a solution for the identification of investigational products, their locations, and for data interchange in clinical trials. Implementing global standards is a good place to start.

 

An industry-led effort

57 companies involved in clinical trials have worked together to develop and adopt an identification and barcoding standard for investigational product kits and their components, a global standard for EDI in clinical trials, and to provide guidance about how to identify locations. These standards form the common language all stakeholders can use to communicate across the clinical trial supply chain.

Example of a product with a GS1
DataMatrix barcode

(01)09501101530003 - Global Trade Item Number

(10)AB-123 - Batch Number

(21)000124pc123 - Serial Number

(7240)PR0044 - Protocol Number

(01)09501101530003

(10)AB-123

(21)000124pc123

(7240)PR0044

 

Global standards unique to clinical trial products

All the standards are intended for use by all parties involved in clinical trial processes, including: manufacturers, sponsors, packaging sites, distributors/3PLs, clinical trial sites, regulators, and patients.

 

An element of trust

The advantages of using a standardised approach to labelling investigational products, identifying locations and exchanging information electronically – accuracy, efficiency, process familiarity, and safety – become an across-the-board benefit that extends throughout the supply chain.

Most importantly, adopting the GS1 Standards for clinical trials adds an element of trust at all levels of the supply chain – a trust that ultimately extends to the patients themselves. And that’s something we can all get behind.

Adopting GS1 Standards adds an element of trust at all levels of the supply chain – a trust that ultimately extends to the patients themselves.