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January 12, 2023


Clinical trial labels across the globe – how to manage translations and country-specific regulations

Bob Bowdish

Senior Account Executive

In recent years, there has been an industry-wide recognition of the need for speed and agility. Accelerating the trial processes for COVID-19 vaccine candidates required proactive and cooperative efforts from participants at all points in the supply chain. A sense of urgency and an expectation that trials should be completed more quickly and effectively emerged because of the realization that a drug can be approved and released to the market in a relatively short period of time. Considering this, improving the speed, accuracy, and agility of clinical trials labeling — and more specifically, the translation of label content — is one of the crucial areas that would help organizations to achieve this.

Now more than ever, the clinical trials landscape touches more regions than ever before. As a result, new studies are grappling with the challenge of managing variable local language labeling requirements. Clinical trial managers have learned that they need to be acutely aware of and able to navigate the complex and ever-evolving web of country-specific regulations and process requirements that can radically differ. One misstep could not only be hazardous to human health but also lead to fines for non-compliance, thus negatively impacting brand reputation and a company’s bottom line.

Navigating country-specific requirements

While many national regulators tend to build on standards introduced by the agencies of major economic players, such as the USA’s Food and Drug Administration and the EU’s European Medicines Agency, there are still many different country-specific requirements that mean clinical trial labels require localization. For instance, most national regulators of EU member states still insist that all local languages are included on all labels/booklets.

In some countries, such as India which is playing an increasingly greater role in clinical research, there are multiple official languages and numerous regional dialects that need to be accounted for to ensure that patients can understand the materials they are provided. Consequently, clinical trials in one country can require several different labels to meet the needs of different local areas or even individual patients within a highly diverse urban setting.

A need for speed

As I’ve already outlined, clinical trial models were accelerated during the pandemic. There was a parallelization of processes, with changes being made to trial protocols at an unprecedented frequency. Each stage of the supply chain needed to function at speed, including labeling and booklet production. These materials needed to be produced on demand so they could reflect the latest changes to trial protocols.

The rapidity of these trials has fundamentally reset the expectations of sponsors, who realized that trials can be conducted at speed across all therapies in development. This not only gets products to market quicker but also maximizes earnings before patent expiration.

If not managed efficiently, label and booklet production can create a bottleneck in the clinical trial supply chain. The requirement for localized labels with translated content further complicates the existing challenge. Translations are often the lengthiest part of the entire process when accounting for the use of translation houses alongside internal reviews to ensure regulatory compliance for each country's label.

Harnessing the power of the cloud

Navigating country-specific requirements is never easy but adopting a purpose-built cloud-based solution for clinical trial label management can help you efficiently manage the process and unlock more agile ways of working. By moving to the cloud, clinical trial organizations will gain access to five key benefits.

#1 Enhanced approvals and version control. A cloud-based solution is the most logical choice for organizations with regional hubs, facilitating the sharing of critical data and helping to minimize the duplication of effort. The overall goal is the establishment of an end-to-end controlled and approvals-based process – from label and booklet design, data integration to print, and finally label inspection – eliminating the potential for human error.

#2 Huge time savings. As the number of countries included in each study increases, with each having specific regulatory content, phrase, and language requirements, so the manual process of designing and approval of country-specific labels represents the most labor-intensive part of generating labels for production. By using a cloud-based solution, it prompts users for study information and then automates the generation of master label text, country label text, and booklet design based on its knowledge of content and design requirements. This reduces clinical label and booklet creation from weeks to hours.

#3 Efficient phrase and translation management. The cloud allows language experts to efficiently manage all stored phrases in their language in one central location. Additionally, clinical trial companies are given access to commercial phrase packs containing text common to all companies and trials that can be used to quickly expand a phrase library. Both features save users time and ensure consistency across label creation.

#4 Access to a regulatory rules engine to keep abreast of changing requirements. A purpose-built clinical trial labeling solution includes a regulatory rules engine to assist with compliance. This will advise, remind, or guide content authors of any country-specific requirements during the artwork design and approval process, including mandatory phrases, font faces, and font sizes.

 #5 Secure data management. When printing labels on-demand, all information and data for inclusion must be collated, including trial data, randomization data, and production data. The clinical labeling solution can source this data from other systems via tight integration into PLM (Product Lifecycle Management) and MES (Manufacturing Execution System), using validated protocols that allow for the secure flow of data with full traceability.

Keeping pace with this highly competitive and increasingly fast-paced industry is no easy feat. In today’s complex world, manually managing labeling and artwork management is no longer viable. Clinical trial organizations need to focus their attention on their labels and booklets, streamline their processes using the cloud, and thereby unlock new ways of agile working that secure operations against potential future challenges.

*This article first appeared in Pharmaceutical Daily

  • Cloud
  • Regulatory
  • Clinical Trials