Talking point

In an increasingly global market for clinical trials, pharmaceutical manufacturers could perhaps do more to mitigate the risks associated with the local language labeling of clinical trial supplies. If companies are to optimize emerging markets, they must adopt a more uniform approach.

The accurate labeling of pharmaceutical products is imperative to safeguard patient safety and meet legislative requirements. But with clinical studies now being conducted all over the world, local language labeling has grown in importance. And it has implications right across the supply chain. With most languages subject to localized nuances, achieving accurate translations remains a great challenge. And with trial data, randomization data and production data captured across a range of systems, managing the process is made even more complex. The challenge is further muddied by country-specific regulations and, of course, the widespread industry objective to reduce costs and improve efficiencies.

To succeed, organizations need an integrated data management system to bring version-controlled information from all systems together to print at the point of dispatch.

But at present, many companies struggle to find a reliable way of approving and locking down local language data – heightening the risk of products being incorrectly labeled. There remains huge variability in how organizations across the sector are managing this key process. The lack of a uniform approach to clinical trial labeling is building avoidable inefficiencies into the supply chain – leading to an increase in unnecessary and duplicated quality checks, the deceleration of product to market and an escalation in development costs.

Companies must therefore collaborate to bring disparate processes together in a single, secure, version-controlled and auditable process to manage every stage of label lifecycle management; from the physical translation and storage of phrases, to the design of labels, final printing and post-print verification. The introduction of a single-solution strategy can help organizations reduce errors, remove duplicate quality checks and eliminate the costly and avoidable return of materials.

The tools to progress already exist. Innovative new label lifecycle management (LLM) solutions can provide connectivity and visibility right across global organizations. Furthermore, they can enable standardization and ensure that processes are controlled centrally, distributed locally and accommodate local language and country-specific requirements.

LLM is data-led, with labels considered merely the final output. The best solutions give companies a 360° view of all their data assets, enabling an integrated organization-wide approach to production processes. They provide a centralized platform that can be leveraged across all sites, regions and divisions – and are interoperable with existing enterprise systems. Moreover, these scalable web-based tools deliver complete label integrity – from data management, design and approval, through to label production and inspection – to meet strict regulatory requirements.

As pharma seeks to exploit opportunities in developing nations – as well as improving performance in traditional markets – there is little doubt that packaging and labeling processes could be more efficient. Historically, companies have managed the design, data management and print process as three distinct and separate areas – in the process, building in multiple manual visual checks to ensure quality control. This is costly, inefficient and vulnerable to human error. Labeling solutions cannot sit in isolation, they must be built into a 360° view of all variable data components.

LLM solutions can facilitate a more strategic approach to the management of global data, and help companies capture, store and disseminate data quickly, safely and accurately. The benefits are significant. LLM platforms can reduce unnecessary manual checks, improve quality control by optimizing automated validation systems, and accelerate market access. Centralized data creates a platform for a ‘single version of the truth’ that can be used to generate labels ‘just in time’ – ensuring that the right information goes on the right product at the right time, every time. And holistic systems enable production managers to ensure no errors have crept into the process; vision verification solutions carry out automated audits, assuring approved imagery and data has been printed correctly on every label, as well as delivering lifecycle traceability. In short, LLM provides data visibility for stakeholders right across multi-national, multi-site organizations.

360° systems that can capture and manage data right across a trial, and bring it all together at the right time, could transform the industry’s approach to clinical trial labeling and reduce the cost of drug discovery. In a competitive multi-language, multi-country marketplace, Label Lifecycle Management can standardize labeling processes and ensure that stakeholders across a pharma company’s value chain can, quite literally, overcome the language barrier and assure regulatory compliance.