Enabling standarisation in the clinical trial supply chain
What if we all spoke the same language in clinical trials?
“With this GS1 standard on identification of investigational Product, we are moving from a study specific approach to global and harmonized standards.
This will dramatically simplify our processes and relationships with all the stakeholders along the Clinical Supply Chain and open up the way for all Pharmas to a global process harmonization which will benefit the Clinical Sites and the patients.
Sanofi is strongly committed to implement this standard to speed up its adoption widely on all clinical trials.”
R&D Clinical Supply Chain Chain Operations, Industrial Development, SANOFI
“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
“Our experience with the current pandemic, made us more aware of the importance of a very efficient supply chain. Standardising communication between the supply chain partners, using EDI is going to get us there.”
Director, Global Traceability & Standards at TraceLink
“It is very important for all of the clinical supplies from different companies to use the same standard. So that hospitals and clinics that conduct clinical trials for multiple sponsors can use one scanner, one system to manage the transaction.”
Executive Director at Pfizer
“We always look for standardisation in order to get a simple solution that can apply to most of our clients.”
Nicolas Le Rudulier
Head of Innovations, Group Synergy Development & IT
“Global standards will allow pharmaceutical companies to concentrate on what they are actually best at. That is to develop high quality drugs that are effective and safe to use for patients.”
Senior Information Scientist at Boehringer Ingelheim
“Now with the global standard and the opportunity for every stakeholder to understand the content of the GS1 barcode that identifies a kit, the communication is much more streamlined. Everybody is speaking the same business language.”
R&D Clinical Supply Chain, Industrial Development Project Manager at Sanofi
“The implementation of the new EDI standard would allow us to take less time and less paper to order investigational products and to make our process more secure.”
Hospital Pharmacist at CH Victor Dupouy
“By using Global Location Numbers (GLN), we will be in a better position to ensure we know where the investigational medical products are in the supply chain.”
Vice President Global quality, Regulatory and Compliance at DHL Supply Chain
Global standards by the industry
The new global standards are the result of an industry-led working group:
Clinical trials organisations
Pfizer and Sanofi
hospitals, IT solution providers,
contract research organisations
...for the industry
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
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
(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
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.