Complexity around the management of labeling for clinical trials is not a new phenomenon, especially when you consider the need for most research to be done on a global scale – aligning not only to local language languages, but also local regulations and processes. In recent years, however, we have seen a surge in demand for supporting organizations capable of delivering agile clinical trials for all therapies in development so that drugs and devices can get to market faster and maximize earnings before patent expiration.
An agile approach requires each stage of the clinical trial supply chain to function at speed, including label and booklet production. However, the requirement for localized labels with translated content is a significant logistical hurdle and can result in a bottleneck as translations are often the lengthiest part of the entire process when accounting for the use of translation houses alongside internal reviews.
Barriers to the production of clinical trial labels and booklets at speed
Agile clinical trial models tend to involve accelerated decision-making, parallelization of processes and changes to trial protocols at an unprecedented frequency. Consequently, labels and booklets need to be produced almost on-demand to reflect the latest changes. This is no easy feat for several reasons.
Firstly, country-specific requirements mean clinical trial labels require localization to account for the different regulatory requirements, especially those relating to languages. When running a trial across many different countries, this means accounting for multiple official languages and numerous regional dialects to ensure compliance and understanding from patients. Furthermore, target countries are subject to change at short notice due to the availability of eligible patients, meaning the supply chain for any clinical trial needs to be able to quickly adjust and accommodate new regulatory and language requirements.
Secondly, sponsors are moving away from the global hub model and increasingly introducing regional hubs to speed up delivery to trial sites while improving supply chain resiliency. The use of multiple distribution sites can introduce inefficiencies and additional risk unless robust systems and processes are put in place to minimize the duplication of effort and avoid inconsistencies in translations.
Finally, the management of multiple assets also poses challenges as there must be complete consistency of translated phrases used throughout a trial. In addition, after the contents have been translated and/or other country-specific requirements are fulfilled, booklet and label designs suitable for one country may not be suitable for another due to available space for content.
Finding a solution
To effectively address these challenges, organizations require a clinical trials labeling solution and accompanying systems based on GxP (Good x Practice) compliance. 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 error.
A cloud-based system is the most logical choice for organizations operating regional hubs, facilitating the sharing of critical data and helping to minimize the duplication of effort. It will integrate specialist functionality including translation management tools and a regulatory rules engine to eliminate time-consuming and costly manual processes while integrating into other systems using validated protocols that allow for the secure flow of data with full traceability.
Introducing Loftware Prisym 360
Navigating country-specific requirements is never easy but a purpose-built solution for clinical trial label management can help you efficiently manage the process, unlocking more agile ways of working. With Loftware’s Prisym 360, you can improve the quality, speed, and efficiency of labeling. The cloud-based solution was designed for clinical trial label management and includes specialist features to efficiently manage the translation process within a GxP environment.
Prisym 360 can help save valuable time and money with its valuable phrase library functionality which allows users to build a collection of approved translated content eliminating the need to repeatedly employ the services of a translation house. In addition, its regulatory rules engine can be configured to evaluate asset designs to ensure compliance with country-specific requirements.
While the requirements for localized labels with translated content can be complex, an effective purpose-built solution can alleviate the pain, allowing you to efficiently manage clinical trial labeling, and unlocking new agile ways of working.
Download our free new report, Optimizing the speed & accuracy of clinical trial label translations, for further detail on how a clinical labeling solution can help you navigate country-specific requirements in the agile era.
About the author
Bob Bowdish, Clinical Trials Sales Manager, Loftware
Bob Bowdish is Director of Clinical Trials Sales North America at Loftware. He has over 25 years’ experience in the life sciences in commercial and research development. His last five years has been helping life science companies leverage regulatory and clinical software to realize efficiencies that result in delivering treatments to the patients they serve.
Bob’s diverse healthcare experience gives him the insight on how regulatory and clinical data can contribute to commercial success. This insight has proven to deliver innovative software solutions that have shortened time to market and enhanced patients safety.