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Improving Data Management to Mitigate Risks in Clinical Trial Local Language Labeling

The question of how pharmaceutical R&D and clinical supplies organizations control source data for local languages is currently one of the biggest issues facing clinical trial labeling and packaging. 

At present, companies struggle to find a reliable way of approving and locking down local language data - leading to the ever-present risk of products being incorrectly labeled, causing financial implications and risk to patient health.

Clinical trials are of course a global activity. As such, clinical trial materials are now being shipped across many countries and many continents. Labeling, booklets and where necessary Instructions for Use (IFUs) must therefore be safely and accurately customized not only so that they are in the appropriate local languages, but also to ensure that the nuances of those individual languages are understood appropriately to communicate coherently with clinicians and patients. They must also comply with country specific requirements; in certain countries additional information, such as the name of the trial organization or specific medication disposal notices, has to be stated by law.


There is currently a huge degree of inconsistency in how organizations across the sector are approaching this important issue – some of which are prone to human error. Where companies have developed in-house processes, there are often a number of disparate systems involved in managing language, label/booklet design, approvals and final printing. Conversely, some organizations still rely on onerous manual processes – at great cost in terms of manpower and money.


The industry-wide multiplicity of approaches to clinical trial labeling is building avoidable inefficiencies into the supply chain leading to an increase in quality checks, the deceleration of product to market and in the process, an escalation in development costs.


Clearly, continuing with such an inconsistent and variable approach as trials become more complex is no longer sustainable. The clinical trial sector – as well as participants in clinical trials – will undoubtedly benefit from adopting a more uniform, consolidated approach to labeling. The challenge is both global and ubiquitous. Pharmaceutical manufacturers, clinical supplies companies and supply chain experts must therefore collaborate to bring disparate processes together into a single secure, version-controlled and auditable process to manage every stage of the label lifecycle management; from the physical translation and storage of phrases, design of labels and booklets, to the actual final printing and verification. By implementing a single solution strategy, organizations can reap the benefits of removing errors, reducing quality checks and eliminating the unnecessary and costly return of materials.

As pharmaceutical companies battle to contain rising development costs, improve efficiencies and increase ROI, integrated label lifecycle management can make a key contribution to some of the industry’s biggest operational goals.

The current environment
The supply chain journey for clinical trials materials is undoubtedly complex and variable. Treatments, comprising various percentages and levels of a drug and placebo, are packaged to be distributed to clinical trial centers for eventual use with trial participants. The packaging and labeling are handled either by the pharmaceutical R&D organization itself, a clinical supplies company or a combination of the two. But, with clinical trials now being conducted on a global scale, the ultimate recipient may be located anywhere in the world. And further, both the person administering the trial and the logistics stakeholders responsible for the drug’s safe and appropriate delivery, will most likely speak a different language. Attaching the right label and more specifically the accurate correlation of the right recipient with the right dosage levels is therefore critical.

In fact, such is the significance of this part of the process, use of the term ‘label’ is perhaps misleading. In this instance, labeling is much more than the simple communication of addressee details, it is the platform for the delivery of key information, crucial to the safe and appropriate transportation and administration of high-value medicines, leading to the reliable monitoring of its effects on patients. More often than not, ‘labels’ are actually 40-50 page booklets – covering a similar volume of local languages – that are affixed to trial materials via an adhesive backed booklet . These booklets are printed in bulk – with critical ‘variable’ information such as the patient’s name, product use-by date or a patient’s identification number – ‘overprinted’ on the front page.

The challenges
In a multi-country, multi-language clinical trial environment, managing such a comprehensive range of variable data is a huge issue. To achieve the timely, safe and cost-efficient delivery of materials to a global user-base, companies face a number of challenges. Primarily, they must not only ensure that information is presented in the native language of its intended recipient, but they must also make sure that translations – most often from English into a local language – capture the subtleties and nuances of that local language. How can companies create and manage a database of phrases, ensure they are translated appropriately and integrated effectively into the version control process? The storage and approval of local language data is key.


In addition, there is also a large amount of local legislation around country-specific label design. For example, information requirements in Germany are much greater than in some other parts of Europe which, as a result, means that single-panel labeling in that country will, by law, need to be different. Once again, this creates additional data, all of which needs managing effectively. At present, companies have various systems in place to manage this – some of which are very good – but few, if any, are joined up. As a consequence, pharmaceutical companies need to do more checks throughout the process – with cost implications in terms of time and expense.


The pharmaceutical sector is, of course, heavily regulated. Companies work hard to mitigate risk and ensure quality control, and comprehensive standard operating procedures, understandably, mean that they conduct frequent and rigorous checks to maintain compliance. However, there are existing tools and techniques that can be optimized to provide a proven and reliable way of versioning control and managing data that can, in the process, reduce the number of checks companies need to conduct and deliver significant efficiency gains.


And finally, once they have aggregated and consolidated local language data and country-specific label design requirements, companies need to output it to a single-paneled label for print, or put it in a format that can be picked up by a third party that can print the booklets without having to go through further onerous checks. This final aspect is, perhaps, most crucial – with errors at the printing stage likely to be most costly. More effective use of technology can help provide companies with secure access to information in the system at every stage through the process – enabling stakeholders to monitor progress, evaluate quality and, critically, inspect print outputs. A creased print ribbon or poor ink quality can lead to unreadable barcodes or incompliant documentation which can mean high volumes of product returns. In cases where drugs have a short shelf-life, this can mean that by the time relabeling has taken place, the treatment is out-of-date, which in turn needs to be thrown away and remade.


Labeling errors can therefore have extremely costly implications. The use of technology that provides secure, remote system access can give companies greater visibility, greater control and greater confidence that all aspects of the process have been managed effectively.

Step change to greater efficiency
There is little doubt that the packaging and labeling process could be much more efficient. Historically, companies have managed the design, data management and print processes as three disparate areas – and built in multiple manual visual checks to ensure quality control. To progress, however, the industry could adopt a more integrated approach, underpinned by robust and reliable automated processes. Holistic systems can capture and manage data right across a trial, and bring it all together at the right time. Moreover, in an industry committed to accelerating the speed and containing the cost of drug discovery, integrated web-based solutions that support an end-to-end process including automated post print vision inspection will provide a strong platform for the natural introduction of ‘just in time’ printing – which will undoubtedly further reduce the need, and associated cost, to print multi-language labels and booklets in bulk.

Tools that provide management across the entire labeling lifecycle can reduce the unnecessary duplication of checks further mitigate risk and significantly improve ROI. For industry stakeholders in Clinical Supplies Operations, the question is a simple one: are you doing enough to drive efficiencies and increase costs-savings throughout the labeling process? The answer will most likely come through taking a collaborative approach to an industry-wide challenge, and optimizing technology to deliver a single secure, version controlled and auditable process to manage the entire label lifecycle. The price of failure is significant, but the solution is within our reach.