Brian Sheridan
VP Global Adherence & Clinicals, Smurfit Westrock
With clinical trials being essential for the development of new treatments, digital display labels (DDLs) offer a transformative technological solution to help address complex supply chain challenges while helping patients receive the prescribed medication faster.
The Smurfit WestRock team at Dublin Glasnevin’s dedicated Adherence and Clinicals facility is set to open a new global Centre of Excellence in 2025. Featuring advanced digital production and bespoke DDL manufacturing, the facility will revolutionise clinical trial supplies with digital labelling, improving efficiency in managing investigational medicinal products (IMPs) and accelerating vital medication delivery to patients.
Challenges of expiration date extensions in clinical trials
One of the significant challenges in clinical trials is when the shelf life of IMPs needs to be extended. At the initial stages of drug development, drug stability is not yet fully understood. As stability data becomes available, there may arise both a need and an opportunity to adjust expiration dates accordingly. This often requires recalling drugs from clinical sites and relabelling them. Relabelling involves retrieving the product, removing it from its original packaging and reassigning it with updated expiration dates.
During this process, and within a complex supply chain, the drug product must stay compliant with regulatory and quality protocols. The relabelling process may extend trial timelines and present challenges, including higher resource demands and potential for increased waste.
Delays, error risks and increased waste
Repackaging and relabelling require additional supply chain control measures. Adding or removing labels, particularly in blinded studies (where uniformity of package presentation for IMP and placebo product is key) also increases the potential risk of labelling errors, as tamper-evident seals are removed from packaging and new labels must be applied.
This relabelling process can extend trial timelines, causing delays as drugs are held up during relabelling and re-distribution. The traditional relabelling process generates material waste and consumes significant labour and resources, driving up overall costs. These challenges make expiration date extensions and relabelling a complex issue, impacting financial resources, trial timelines and patient safety.
Despite their potential, several challenges
must be addressed for DDLs to fully
realise their capabilities.
How DDLs can provide the solution
- Near-real-time updates: DDLs can instantly be updated with information such as dosage, expiration dates and instructions. This eliminates the need for manual relabelling, ensuring patients always have accurate, up-to-date information.
- Improved patient safety: With live updates, DDLs help ensure that patients are always informed. The DDL can even be used to send warnings, when necessary, while the clear digital display minimises the potential for misreading.
- Cost efficiency: While the initial cost of DDLs may be higher than traditional labels, the potential recirculatory model will lower costs over time by eliminating the need for relabelling, reducing material waste and eliminating shipping back and forth between clinical sites.
Considerations for widespread DDL adoption
“Despite their potential, several challenges must be addressed for DDLs to fully realise their capabilities,” explains Brian Sheridan, VP Global Adherence and Clinical. “The first is industry alignment and investment as adopting DDL technology requires significant investment in hardware, software and packaging to ensure smooth implementation and regulatory compliance.”
Second is regulatory approval; DDLs will need to comply with varying local, regional and global regulations. This may require updating or creating new guidelines to accommodate these innovative labels. Third is technology reliability; the electronic components in DDLs, such as the screens and microprocessors, must be reliable and tested to ensure operational consistency throughout the trial.
Lastly but crucially is security; as DDL updates involve remote connection and data transfer, the integrity of the IT infrastructure and related protocols supporting updated IMP information is critical. Software must meet industry standards and operate securely while enabling remote updates to the labels.
Transforming the clinical trial industry
“Transformational innovations that can reshape industries are rare, often requiring compromise in typical step-change developments. However, some innovations offer such significant benefits that they are hard to ignore. Adopting DDLs in the clinical trial supply chain could eliminate the costly and complex process of relabelling IMPs,” adds Sheridan. “They could dramatically enhance operational agility, streamline the industry and ultimately support patients.”
For more information, get in touch with [email protected]
