IN PARTNERSHIP
In summary, when assessing the overall impact of expiration date extensions and the need to relabel the IMP in line with regulations, there are a multitude of areas to consider. These range from the financial – such as the resources required to perform the necessary operations to remain safe and compliant – to the potential human impact within the extended and complex supply chain that puts the IMP at an increased risk of complications, delays, or even failure.
Digitalising clinical trials with Digital Display Labels Utilising new functions and features now available in Digital Display Labels can reduce these issues and provide a technical solution to the challenges faced by the traditional labelling process. Near real-time updates: Live changes of
information, such as dosage, date extensions or instructions to be available to the patient. Improved patient safety: These live changes
ensure the patient is always equipped with the correct information. Not only that, but the DDL can also send warnings during the trial if necessary, while a clear digital display ensures that the potential for misreading is kept to a minimum. Overall cost: While the initial cost of the Digital Display Label will understandably be higher that of the traditional label format, the true cost of the DDL reduces with each reuse through the reduction in time and resource for relabelling, reducing material, and negating the need to ship to and from the clinician. Data collection: As Digital Display Labels are scaled and new innovations and iterations are designed, they may also provide additional functionality. Usage, temperature, and feedback could all be monitored to gain invaluable information. Customising information: Last minute
labelling can provide patients with details specific to them and the clinical study parameters. Multilanguage pages can be used to provide enhanced support, with interactive buttons to guide patients on use.
Challenges to consider The market-wide adoption of Digital Display Labels has clear prospective benefits to patients and clinicians alike. However, we still must
consider the necessary requirements to this exciting new development is correctly positioned to reach its true potential. Investment: The adoption of new
technologies, which will include software, hardware and packaging, must be thoroughly considered to ensure both successful implementation and regulatory compliance. Regulatory: Acceptance of new processes and innovative solutions requires detailed considerations for adoption locally, regionally, and globally. This will include the compliance and safety assurances for Digital Display Labels to be used in live studies, within guidelines which may require updating or creating to accommodate such a significant change. Technology reliability: Updates to
technologies within the DDL, including electronic components such as screens and microprocessors, must be performed when required to ensure patient safety. These parameters must be clearly defined, and thoroughly tested to ensure the Digital Display labels reliability and longevity in real world use. Security: Data transferral must be secure to
prevent patient information being available accessed illegally. Software developments should always meet standard data safety requirements, whilst enabling remote updates via the patient.
Pressing forward with Digital Display Labels Transformational innovations that can truly change the landscape of an industry are rare. In typical step-change developments, the key to implementation is usually compromise. However, sometimes there are developments that deliver so many benefits that they are hard to ignore, hard to refute, and hard not to adopt without compromise as the rewards are too great.
With the potential to effectively eliminate
the process surrounding the costly, complex and lengthy process of relabelling IMPs within the clinical trial supply chain, adopting Digital Display Labels throughout the industry has the potential to drastically improve operational agility and ultimately to help patients get their medication quicker.
For more information, please scan QR code or contact us at
healthcareinfo@westrock.com
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