New application standard for identification of investigational products in clinical trials


Following a 9-month collaboration of 37 clinical trial organisations from around the world, GS1 has released an open application standard to support the management of clinical trials. 

Cinical Trials Standards

At any given time, pharmaceutical companies support hundreds of clinical trials happening across the globe. Each of these trials can impact hundreds of thousands of patients and tens of thousands of clinical trial sites ranging in size from the world’s largest institutions to individual practitioners. In fact, a single late-phase study could involve as many as 1,000 different investigators.

Today, most pharmaceutical sponsors identify and name their investigational products in their own unique way, using their own packaging and labelling. Although these products are usually serialised and barcoded, they do not comply with international standards.

At the other end of this supply chain is the clinical trial site, who faces the daunting challenge of managing hundreds of trials across multiple suppliers. Due to a lack of standardisation at the top of the supply chain, these trial sites find themselves having to manually re-label packages in an attempt to manage investigational products. The result is that many sites end up managing as many different systems as there are sponsors of research sites

Not only is this fragmented process expensive – it’s also potentially prone to errors. What the industry needs is a solution to consistently identify investigational products along the entire supply chain.


Implementing global standards is a good place to start.

View the GS1 Global Office Website for more information.

Source: GS1 Global Office