Labeling is one of those fascinating Clinical Trials topics that our consultants have been involved in for over ten years. Printed labels and booklets are still the norms for Investigational Medicinal Products (IMP); however, it does not come as a surprise that companies are looking into options to go paperless. Electronic labels, or e-labels, have become buzzwords in the Life Sciences industry the last few years. We see a similar trend in the broader area of batch records, but most companies have a long way to go.
We strongly believe in the future of e-labeling but recognize, for many years to come, only a hybrid solution is realistic. Not much may change to printed labels; the same label will be available in electronic format and readable on electronic devices. All the while, e-labeling functionality can be further optimized, and regulatory agencies can be supplied with more data to support any changes in regulations to accommodate some form of e-labeling.
The more prototypes and successful pilot studies that can be referenced, the higher the probability that supporting legislation will eventually follow. The speed of adoption will vary per country/region; they all have their own complexities, and it's better not to skip steps in the growth toward a more mature business model. In the US and Japan, for example, the expiry date is not always required on the label, making any retest date extensions easier to manage. These markets allow for less risky pilots.
Label management tools
During clients' Label Management selection processes, we perceived a strong user preference for standalone label design solutions with focus on 'WYSIWYG' (What You See Is What You Get) flashiness, drag & drop, easy preview, etc. This makes sense at first sight; however, it should not be the main selection driver.
Life Sciences companies are building or further enhancing end-to-end Clinical Supply Chain functionality in their ERP, and while ease of label design is a factor, the focus should be on standardization of templates, de-duplication of phrases, improvement of approval processes, etc. These are all contributing to the very long lead times from initial design until approved label for a specific language and country; six months is no exception.
Don't let a flashy e-labeling app prototype fool you. It's important to have a user-friendly solution to interact with patients and clinical sites; however, it is truly critical to have full control over how data flow, while maintaining patient privacy, study blinding and having full traceability, just to name a few. An app offers no guarantees as a standalone.
Integration of clinical data
With our experience in solution design and data conversion during multiple Clinical Supply Chain implementations over the years, we have gained deep understanding in both the bigger picture and the complex data flows in the Clinical Trials space and labeling. In particular, from planning at the Active Pharmaceutical Ingredient (API) level through delivery at the sites and consumption and patient tracking in the Interactive Response Technology (IRT) system with full control and traceability along the way.
Whether you print your full label or only a language-neutral basic physical label for the e-scanning purpose, you still need access to the same data for display on a mobile device and the web, after, e.g., scanning the barcode. You need a solid foundation, and an integrated ERP solution has many benefits. If you have a solid data foundation, with, e.g., your phrase library and study data, this can be made available in a web version without huge technical complications.
An (electronic) labeling solution deeply integrated into your ERP setup has many advantages, including direct access to data in the areas of Clinical Study Data, Compound Information, Planning, Blinding, Randomization, Packaging, Initial & Extended Retest Dates, Material Master, Regulatory Status, Phrase & Label Approval Status, Security, etc.
Connecting a system-driven Retest Date Extension process to your labeling solution, for example, can be very powerful and ultimately lead to even more time- and cost-saving when an electronic push can replace the complexity of physical relabeling.