New standard for investigational products answers clinical trial industry’s need for consistency
“The standardised barcode format will be a valuable tool in securing the circuit of investigational products. It will also, by limiting internal re-labelling and transcriptions, save time and improve the management of the inventory. In our site, it will be a great incentive for the development of computerised investigational products’ management.”
Service Pharmacie, CH Victor Dupouy
“Moving closer to the GS1 standard for identifying commercial pharmaceutical products seemed to CREAPHARM CS to be the most consistent approach to do this. It is for this reason that today we have agreed to participate actively in the working group dedicated to this standardisation and for the following we will implement the new DataMatrix dedicated to the clinical trial products.”
Nicolas Le Rudulier
Head of Innovations and Group Synergy Development & IT, CREAPHARM - Clinical Supplies
“While all pharmaceutical sponsors identify our investigational products in a unique and traceable manner, there is a lack of consistency across the industry in exactly how we do this. This lack of standardisation makes it harder and more time consuming for clinical trial sites to receive and dispense products.”
Senior Advisor, Product Delivery and Supply, Eli Lilly and Company
The new global standard is the result of an industry-led working group:
blinded and unblinded trials
Global Trade Item Number (GTIN)
for unambiguous identification of investigational products and their components
No requirement to include expiration date within barcodes
constraints of labelling small kit components
Adopting GS1 Standard adds an element of trust at all levels of the supply chain – a trust that ultimately extends to the patients themselves.
This application standard focuses primarily on the identification and barcoding of investigational products from the time of kit assembly to use and, if necessary, destruction.
Investigational products include active products, comparators and placebos. Where identification of items outside of this scope, locations, patients or caregivers is required, reference is made to relevant existing GS1 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.
involved in clinical trials
Hundreds of thousands of patients
can be impacted by each clinical trial
Tens of thousands
of research sites
“This lack of standardisation makes it harder and more time consuming for clinical trial sites to receive and dispense products.”
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.
An industry-led effort
Sixty representatives from 37 organisations came together to lend their expertise to developing such a standard. Representing the breadth of the clinical trial supply chain, this industry working group included pharmaceutical companies, hospitals, IT solution providers and contract researcher organizations and was chaired by CH Victor Dupouy, Pfizer and Sanofi.
What the industry group wanted was a global standard capable of enabling processes to work better across borders and around the world. Given its role as the most widely used standard for healthcare product identification and barcoding, the group chose to work with GS1. “Moving closer to the GS1 standard for identifying commercial pharmaceutical products seemed to CREAPHARM CS be the most consistent approach do this,” CREAPHARM CS Head of Innovation and Group Synergy, Development and IT Nicolas Le Rudulier.
The working group was also impressed by GS1’s history of collaboration with other standards development organisations, including the International Organization for Standardization (ISO) and the European Committee for Standardisation (CEN), along with its participation in the Joint Initiative Council (JIC).
Together with GS1, the group met weekly for nine months to draft the GS1 Application Standard for the Identification of Investigational Products in Clinical Trials.
(01)09501101530003 - Global Trade Item Number
(10)AB-123 - Batch Number
(21)000124pc123 - Serial Number
(7240)PR0044 - Protocol Number
Global standards unique to clinical trial products
The GS1 Application Standard for the Identification of Investigational Products in Clinical Trials defines the rules, roles, and responsibilities for the allocation of GS1 identification keys and the barcoding of investigational products, primarily from the time of kit assembly to use and, if necessary, destruction. It is intended for use by all parties involved in clinical trial processes, including: manufacturers, sponsors, packaging sites, distributors/3PLs, clinical trial sites, regulators, and patients.
“Because the sponsor is ultimately the owner of an investigational product and thus knows the product, they are best-positioned to identify it at the source – making it easier for everyone down the supply chain,” says GS1 Global Director of Healthcare Tania Snioch. “This is the basic premise of GS1 Standards.”
Referencing existing international standards used by the commercial supply chain, the new standard includes aspects tailored to the unique needs of the clinical trial environment, including blinded and unblinded trials.
For example, the GS1 Standard introduces the Global Trade Item Number (GTIN) to the clinical trial environment. The GTIN allows users to unambiguously identify the investigational products and their components used in clinical trial kits across the systems and processes of all stakeholders, while at the same time caters to the specific needs of blinded trials. Furthermore, because expiry dates of investigational products can be fluid, the GS1 Standard for clinical trials does not require the barcode to include an expiration date. The Standard also takes into account the space constraints related to labelling small kit components.
An element of trust
A big benefit of using a standardised approach is that work progresses faster and more reliably, and data is compiled quicker, thus accelerating submissions to regulatory agencies. “By limiting internal re-labelling and transcriptions, the GS1 Standard saves time and improves inventory management,” says Olivia Chauvel, Service Pharmacie, CH Victor Dupouy. But it’s not only the suppliers that benefit from standardisation – clinical trial sites do too. With all pharmaceutical sponsors using a common approach to labelling investigational products, it becomes easier for clinical trial sites of all sizes to adopt approaches to data capture that leverage the barcodes.
The advantages of using a standardised approach to labelling investigational products – accuracy, efficiency, process familiarity, and safety – become an across-the-board benefit that extends throughout the supply chain.
Most importantly, adopting the GS1 Standard 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.