The new GS1 standard for Investigational Medicinal Product (IMPs) has been heralded as an important step in clinical trials, improving consistency along the industry’s entire supply chain.
The standard was conceived by an industry led working group of 60 Representatives, 37 clinical trials organisations and weekly meetings over 9 months to replace multiple disparate in-house barcode solutions.(Source GS1)
GS1 has been adopted by clinical trials because it will improve consistency across the industry’s entire supply chain. Identification and barcoding of IMPs from assembly, to use and if required, destruction. Increased globalisation means that the supply chain is more likely than ever to cross-borders, so standardised barcode symbology and structure is vital in proactively managing those risks.
The complexities of meeting a GS1 standard require you to have a labeling solution that can meet the practicalities.
Legacy labeling software may not support both the GS1 datamatrix barcode and the new AI (7240).
A business will need this AI to maintain the standards outlined by GS1 for Clinical Trials use. Industry leaders such as Pfizer and Sanofi have adopted the GS1 standard, so it is important that the industry works in conjunction with change and follows the example set.
This is an added complication to labeling given the imminence of Annex VI. However, this new directive is an opportunity to assess and evaluate your current software and operations. It additionally benefits the supplier, clinical trial sites and patients:
Benefits for Suppliers:
- Data is pulled quicker. Additionally, less time can be spent validating and verifying.
- Full supply traceability.
- Less transcription errors towards the end of the process.
Benefits for clinical trial sites:
- Time efficient
- Stock Inventory is easier to manage.
- Minimises the risk of internalised labeling mistakes and transcriptions.
- It is easy to adopt processes that fully utilise the barcodes.
Benefits for Patients:
- This standard improves patient safety because it is a holistic approach towards risk management. It improves trust across the industry and brings the various components of the supply chain closer together.
A modern labeling solution is required to handle the practicalities of these industry changes. It is important to view changes and trends as an opportunity to get ahead, do not be risk-averse nor stagnant.
A 2D Datamatrix barcode is widely used across all industries via the GS1 operational standards, so adoption of this type of barcode will assist in keeping up with Industry change. It is important to not be left behind.
PRISYM ID are ready to consult and enable your adoption of the GS1 standard in Clinical Trials via the PRISYM 360 clinical trial labeling solution.
About the author
Craig Jones, VP enterprise sales engineering, PRISYM ID
Craig Jones is the Vice President of Enterprise Sales Engineering for PRISYM ID with responsibility for understanding customer needs and industry challenges to drive solutions to improve efficiency, minimise risk, address regulatory requirements and provide new approaches to business systems and processes. Craig has 15 years of experience delivering validated label lifecycle management solutions to life science and healthcare industries including medical device, pharmaceutical and clinical trial organisations. His experience includes roles as an industry consultant, in IT management and as a senior manager for global technical support and professional services.