The operations of the pharmaceutical industry are intertwined with matters of public safety and public health. As such, strict regulatory requirements pertaining to the review and registration of new drugs and generic drugs are in place in various countries. Pharmaceutical companies are required to submit accurate and adequate information in their filings for drug approval and registration that would serve as proof of safety, effectiveness, and consistent quality of the drug in question. Typically, the information submitted can be in the volume of hundreds of thousands, or even millions of words. If the pharmaceutical company seeks to obtain market approval for the same drug in other countries, the volume of translation content will be multiplied with each new target language required. There has been a dramatic increase in the volume of drug-related content in multiple languages. As such, pharmaceutical companies now have an urgent need to make their content management processes more efficient so that they can carry out information collection, management, translation, and risk management tasks for filing processes in a more organized manner. That is to say, how efficiently a firm is able to manage its content will have a direct impact on the success rate of its drug approval filings.
There are many routine management tasks within pharmaceutical companies, such as production management, quality management, document management, and material management. Content management is about making the aforementioned information and data reusable so that the company can save significant time and money on data management and information retrieval. However, many pharmaceutical companies have also come to realize that in the course of their global development, there is also now a need to perform globalization/localization management in addition to routine management tasks. Globalization/localization management tasks can include translation and localization management, multi-language vendor management, and multilingual asset management. This need undoubtedly places even more pressure on the pharmaceutical company’s content management capabilities.
What challenges do pharmaceutical companies face in terms of content management?
- Global development has led to a sharp increase in content across multiple languages. The materials submitted in drug approval filings usually contain hundreds of thousands of words. They include an adequate and reliable amount of drug research data, clinical trial data from various stages of testing, and full and accurate drug descriptions (e.g., drug packaging, labels and instructions for use). As pharmaceutical companies seek development around the world through sales in various overseas markets, filings have to be translated into multiple local languages. If, for instance, a certain company files for regulatory approval for a new drug/generic drug in five countries at the same time, it will not simply be a matter of generating five times the word count in translated text. The need for multi-language translation, multiple localization projects, and quality control in each target language pose significant challenges to the company in terms of content management.
- Lack of coordinated content management within the enterprise. Currently, many pharmaceutical companies do not conduct their internal content management work in a coordinated fashion. There is little exchange and communication among various departments, such as R&D, Clinical Testing, and Regulatory Approval, with each department responsible for content management in its respective area. There are even cases where different departments within the same company work with different language service vendors. Such a lack of coordination can make content management chaotic within the company and negatively impact the process of drug approval filings.
- Cost of compliance operations keeps rising. The cost of regulatory compliance for the pharmaceutical industry is also keeping rising as regulatory requirements for drugs become even more stringent in various countries. If the drug package insert text is found to be non-compliant, the pharmaceutical company then has to revise the text so that it meets the requirements of the regulatory agency concerned. In addition to paying an additional cost for the re-translation of the text and replacement of package inserts, the company will also have to carry out a full benefit/risk analysis of the text as well as publicity and training efforts centered on clinical use and safety issues. As such, reducing the cost of content management has become a growing imperative in life sciences, particularly in the pharmaceutical industry.
In general, the efficient and organized management of content facilitates the drug approval filing process and contributes to content quality. However, in the process of launching products to more markets worldwide, decision-makers in the enterprise have focused their energies on global communication, clinical testing, and compliance strategies. Most enterprises have little energy or budget left for content management as a result.
What is System Integration?
For a long time, enterprises have used Content Management Systems (CMS) to manage their content; however, as they grow and develop in overseas markets, pharmaceutical companies find that a CMS can no longer meet their needs in a number of areas, such as translation and localization management, vendor management, and language asset management. They spend millions of dollars on Content Management Systems each year. The cost of switching to a new system is also prohibitively high.
EC Innovations offers a Localization Process Automation (or TBMS LPA) solution that is specially designed for end-to-end content management. This is a solution that can be seamlessly integrated with the enterprise client’s current content system (such as CMS or VCS) or business applications (such as Email). TBMS LPA provides the enterprise with real-time monitoring of localization management processes and fully connects the enterprise’s content system with EC Innovations’ network of high-quality translators as well as performs automated quality assurance. Read: “Success Story: Translation of New Drug Applications for the FDA” to learn more.
How can pharmaceutical enterprise tackle its content management issues with System Integration?
- Automated processes make localization management more efficient for pharmaceutical companies. After the content systems of both parties have been integrated through TBMS LPA, the pharmaceutical company may simply create and upload a translation project within its own CMS, thus saving it time that would be otherwise spent on multiple emails, faxing, and telephone calls. The enterprise can even directly obtain translation/localization project data — such as project process design, translator selection, corpus (the glossaries and translation memories are known collectively as “the corpus”), project schedule, and quality assessment report data — through its CMS by means of a connector. The pharmaceutical company will hence be able to realize more organization in its content management with fewer assigned personnel.
- Centralized and systematic management of language assets. TBMS LPA comes with the Cloud CAT (Computer Assisted Translation), corpus management, and Online QA functions. Cloud CAT even allows for the centralized storage of project documents, glossaries, and translation memories. Translators can perform their work in a standard format on Cloud CAT, and also refer to the latest terminology lists and translation memories in real time for greater productivity while ensuring output quality and consistency. If the enterprise does not yet have a corpus, EC Innovations’ Subject Matter Experts (SMEs) for the pharmaceutical industry can also create and maintain language assets upon request by the client.
- Lowers management costs. TBMS LPA can add a high-degree of automation to the localization process and thus significantly reduce on the cost of manual management. Language asset management and maintenance are made highly efficient for the client through the cloud-based translation and corpus management system; additionally, an expansive set of high-quality language assets can also help achieve more cost savings for the client. Online, our SMEs provide translators with real-time compliance training on the drug approval filing process to help the enterprise avoid additional compliance-related costs.
- Quality assurance across multiple languages. Once a translation project is kicked off, we select the most suitable native-speaker translator for the project using a smart matching function based on factors including the language(s) the translator excels in, education, experience in translating for the pharmaceutical industry, translation quality rating, geographic location, time difference, and the workload already assigned to the translator. TBMS LPA can assign a quality rating to the translation based on predetermined translation quality standards. QA reports can be generated in real time to help the enterprise project manager keep track and manage the translation quality.
With this System Integration solution, EC Innovations is able to provide the client with translation/localization management and language asset management services with high efficiency. All the client has to do is keep track of project status, take automatic delivery of the project, and evaluate the quality of the translation/localization services received through the company’s CMS. This helps the enterprise cut down on management costs even more, and to even better focus its energy on its global market and compliance strategies.
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Our recommendations for localization content management
- Establish a dedicated Localization department that manages content throughout the company.
- Establish long-term and transparent working relationships with language service vendors that are professional and reliable.
- Work with a single language service vendor that is able to provide you with services for multiple languages, as this will make content management more straightforward and save you more on localization costs. In May 2018, Electronic Arts stated in a SlatorCon interview that in cases where budget is an issue, the company would first seek multi-language services from a single source, because this helps save drastically on costs.
- Organized and efficient content management is of great value to the enterprise’s development. Vendors offering services for multiple languages can, to a large extent, take on the pharmaceutical company’s burden in the areas of multi-language content management, translation and localization management, and language asset management.
About EC Innovations
Having accumulated over 20 years of experience, ECI has gained a competitive edge in translation productivity, technology accumulation, quality control, and overall efficiency in the life sciences field. In addition to providing professional translation services, we also provide advanced localization technology solutions to maximize translation and localization efficiency and achieve automated project management.
To date, ECI has achieved ISO 13485:2016, ISO 9001:2015, and ISO 1710:2015 certifications. We have 11 strategic offices around the world and operating divisions in Asia, Europe, and North America, offering full localization support into 120+ languages and 260 locales.