MedDRA –
Medical Terminology Localization for a Major Pharmaceutical Company
Project Background
In today’s global community, medical companies are increasingly aware of the importance of accurately interpreting clinical trial results in order to obtain international regulatory approval for their drugs and medical devices.
Since many of these trials and studies are conducted in foreign languages, it becomes crucial that the results are accurately translated back into English and other required languages. MedDRA, or the Medical Dictionary for Regulatory Activities, is designed to be the new global standard for medical terminology and product development process for the global market.
Major global regulatory authorities (within the US, Europe, and Japan) are adopting MedDRA and moving toward requiring its use. The FDA, for example, has already implemented MedDRA within its Adverse Event Reporting System (AERS). European authorities are beginning to use MedDRA as a key part of their electronic database systems. The current MedDRA database only provides multilingual terminology for six languages including English, German, Spanish, French, Portuguese and Japanese. However, our client wants to extend the language set to Simplified Chinese.
CSOFT was contracted by a major pharmaceutical company to supply the entire translation into Simplified Chinese and provide updates to the other six existing languages.
The Challenge
Medical terminology is highly technical and requires substantial knowledge and experience in the medical field in order to accurately interpret and translate each term. To obtain precise definitions, each term often requires substantial research and analysis using a variety of medical studies and references.
For this project, the terminology was divided into five different MedDRA levels: SOC, HLGT, HLT, PT, and LLT. The terms at the SOC, HLGT, HLT, PT level represent unique medical concepts or groupings and therefore must be uniquely translatable.
No given translation can be used for more than one English phrase even if the phrases occur at different levels. Most, if not all, of the LLTs, also needed to be uniquely translatable. The combination of highly technical medical terms and the special requirement of MedDRA levels made this project unique and challenging for any localization company.
The CSOFT Solution
Before officially kicking off production (as with most of our localization projects) we assembled a designated project team with qualified translators/reviewers (see qualifications below), a client service/project manager (CS/PM), and an onsite project team leader (PTL) for the MedDRA project.
Team members used the planning phase to analyze and process all project requirements such as translation instructions, MedDRA background information and other related references for preparation of project execution.
Qualifications
Because of the unique requirements of MedDRA, we assembled a team of professional medical translators with solid training and experience in medical translation. Many of them are post-doctoral degree candidates at the Medical School of Beijing University and China Union Medical College (both highly respected institutions in China’s medical field), and other medical professionals.
We also selected two senior members of the Chinese Pharmaceutical Association and State Drug Administration (SDA) for translation review. Some of our translators/reviewers are publishers of major Chinese medical journals such as China Journal of Medicine and China Clinical Journal of Medicine. In order to meet both quality and our aggressive deadline, the project team developed a detailed project workflow based on our standard L10N processes to maximum translation quality and efficiency.
The following illustrates some of the important components for the MedDRA localization process:
File preparation
The project manager working with our L10N engineering team prepared a well organized L10N Kit complete with translation tables in Excel, client translation instructions, CSOFT internal guidelines, schedule outlines and a list of medical reference materials. This L10N Kit ensures that all project related information is handed off to the translation team.
Initial Translation
Working with the localization kit and a list of medical references such as Dorland’s Illustrated Medical Dictionary and International Dictionary of Medicine and Biology, our medical translation team completed the initial translation within the required time frame. Any translation issues (technical or linguistic questions) were quickly communicated to the project manager and then to the client via CSOFT’s standard translation query report.
Review & Editing
Once the initial translation was completed, the localized terminology list was handed off to our internal medical review team for proofreading and editing. The review team used the same set of translation instructions and reference materials to proofread the translated terms. The edits/changes were implemented by the initial translation team.
Expert Review
Selected portions of the terminology translations were reviewed by outside experts from China’s State Drug Administration. Since the MedDRA database demanded the highest quality translations, the Expert Review cycle ensured that our translations had the professional accuracy required by the State Drug Administration. All comments and edits were reviewed by the translation/review team and project team leader.
Client Review
As with most projects, CSOFT sends back portions of the translation for client review. In the case of MedDRA terminology translation, we decided to send the complete translation for review by our client. With our three step approach for translation, the client reviewers found little or no changes to the translated terminology. All client changes were implemented by the translation team and the resulting translation memory was updated to ensure consistency.
Post-Translation Processing
Because of the unique requirement of the MedDRA project, all translated terms had to be thoroughly checked for duplicates and conflicts across the five different MedDRA levels.
Initially, our team had to go through the translated terms manually to eliminate duplicates and resolve conflicts. However, the task quickly became overwhelming considering the number of terms involved (75K) and the complex relationship among the five different MedDRA levels. Our team conducted a number of project meetings to develop alternative solutions. Thanks to CSOFT’s technical development experience, the project team decided to create a relational database so the terms could be sorted by levels and compared automatically. Automating this process not only helped save time and money but also eliminated potential human errors. Taking advantage of CSOFT’s strong engineering capabilities, the team was able to quickly build a customized relational database to automate the task and complete the project on time.
The Result
The MedDRA database was successfully launched in Simplified Chinese on-time, on-budget, and with the highest quality translation.
The client was so impressed with the MedDRA translation and our technical solutions that they decided to use CSOFT’s relational database as an independent online and fully searchable multilingual MedDRA search engine for all existing languages. It took CSOFT a little more than two weeks to develop the online search database with full Unicode enabling so that all languages could be searched and compared at the same time.
In November 2004, our client officially submitted the Simplified Chinese MedDRA database to China’s commissioner of State Drug Administration, the equivalent of the FDA in the United States. As an L10N company, we are proud to be part of the official MedDRA translation as this gives CSOFT an opportunity to set industry standards for medical translations. Given this experience, we are confident we will be able to provide both accurate and professional quality translations for your company too.
