Case Study: 4 Day, 50,000 Word Adverse Event Report Form Translation
According to GlobalData’s Clinical Trial Outlook Report, it is expected that roughly 61% of clinical trials will be conducted outside of North America. The need for accurate and easily scalable language services to reach global patient populations has never been more evident. When it comes to adverse event report form translation as a key part of a larger clinical trial, there is no room for error – especially when there are tight deadlines.
Language Connections has years of experience working in the healthcare industry, including clinical trial and life sciences translation for global clinical studies. One of our clients, a large, multinational bio-pharmaceutical company, came to us requesting that we provide adverse event report form translation from Japanese into English for clinical trials they were conducting in Japan for chronic Hepatitis C treatments.
Q: How Do You Translate Large Volumes of Adverse Event Reports
To Meet FDA Deadlines In Only 4 Days?
The Client:
*Due to confidentiality reasons, the client’s name has been omitted.
FDA regulations require reporting within 15 days (at the latest) for any patient adverse reactions, whether serious or unexpected.
Our client for this project was a large, multinational bio-pharmaceutical company based in Boston, Massachusetts. They are known for their studies on the development of medicines targeting the underlying cause of cystic fibrosis, among other diseases.
The company has gone through several successful clinical trials to receive regulatory approval, has drugs on the market, and conducts research throughout the world.
The Challenge:
Language Connections was first approached by the client’s pharmacovigalence unit. When the client came to us, they were looking to procure rush clinical trial translation services as they were concerned that they were not going to be able to meet the 15-day, U.S. FDA deadline for reporting adverse events.
This was due to the fact that the CRO in Japan with whom the company was working with had failed to report the adverse effects of the trial immediately.
- At the time the client approached us, they had 4 days to provide the FDA with 25 translated documents, totaling roughly 50,000 words.
Language Connections was not the first translation agency the company had reached out to with their concerns – the client had already tried with their existing provider, a large, multinational translation agency.
However, with tens of thousands of highly technical words, needing Japanese to English translation no less, the turnaround time was deemed impossible to meet the FDA’s deadline.
Although the situation seemed impractical, the Language Connections team stepped up to the plate to help the client meet their deadlines. In order to do so, our team had to develop a unique solution for the client, very quickly.
The Solution:
When it was presented to the team at Language Connections, the project had 3 challenges that needed to be addressed in order to ensure the translation was done on time, within the client’s budget, and with the necessary accuracy to pass FDA regulations.
- The materials needed to be translated within 4 days
- The content of the materials was highly specialized, and highly technical
- The language pair, Japanese to English, was rare – made more so by the need for rush services for 50,000 technical words
In order to overcome these challenges, the team at Language Connections devised a unique solution requiring precise oversight, and perfect coordination from the project manager assigned to the job.
First
We reached out to the native-speaking, Japanese translators in our global network who not only had proven experience with translation, but also with the highly technical text of the Adverse Event Reports.
This required that the translators have background knowledge in the Life Sciences, as well as in Clinical Trials and FDA regulations.
SECOND
Our specialized translators were located in teams across different time zones. Our in-house translation department coordinated the different groups to ensure that translation could be done around the clock.
This gave us more time to complete the translation than would have been allowed for with standard business working hours.
THIRD
We had one of our expert Japanese translators create a glossary for technical terms relating to the Adverse Event Reports, and the trial itself, to be used by the teams of translators.
This would ensure consistency across all the translations, even though they were being handled by different groups of translators.
FOURTH
We assigned a dedicated, in-house project manager to handle the complex coordination of the projects. The projected manager worked closely with our Japanese translators to ensure all documents were translated accurately.
He was also in charge of the final formatting of the documents, which included multiple tables for each report that had to be created from scratch.
While the project itself was complex, the solution was made possible by our dedicated team of Japanese translators, and the focused attention of our in-house project manager.
A: You Trust Your Clinical Trial Translations To Language Connections.
The Result:
Due to our ability to coordinate the large volume of documents to undergo almost continuous translation, we were able to meet the 4 day deadline required by the client.
Our highly skilled translators and editors were able to scale up quickly while still maintaining the quality and accuracy of these highly sensitive documents.
Thanks to the dedicated oversight of the project manager, and the translators’ knowledge of regulations and specific terminology related to pharmacovigilance, a full and appropriate Adverse Event Report Form translation was delivered within a time frame that all other providers were unable to accommodate.
Our solution also allowed us to avoid costly rush fees – often incurred when projects are highly technical, and needed in a very short time-span. The client was pleased with both the quality and the time-frame within which we delivered the product, and was able to deliver the reports successfully to the FDA.
A: Trust Your Clinical Trial Translations To Language Connections.
The Result:
Due to our ability to handle large volumes, we were able to meet the 4 day deadline required by the client.
Our highly skilled translators and editors were able to scale up quickly while still maintaining the quality and accuracy of these highly sensitive documents.
Thanks to the dedicated oversight of the project manager, and the translators’ knowledge of regulations and specific terminology related to pharmacovigilance, a full and appropriate adverse event report form translation was delivered within a time frame that all other providers were unable to accommodate.
Our solution also allowed us to avoid costly rush fees – often incurred when projects are highly technical, and needed in a very short time-span. The client was pleased with both the quality and the time-frame within which we delivered the product, and was able to deliver the reports successfully to the FDA.
Interested in Learning More About Language Connections’ Work in the Life Sciences? Check Out The Following Resources:
About Language Connections:
Language Connections is one of the top language service companies in the US. Over the last 30 years, we’ve focused on providing the best business translation services, interpreting services, as well as interpreter training and customized language training programs. In addition to top-tier corporate language training, we offer certified corporate interpreters and professional business translation services in 200+ languages. Our network includes linguists with backgrounds in all major industries. They’re ready to meet your needs, whether they’re for technical translation services, legal translation, government translation services, international development translation services, education translation services, life sciences translation, or something else. Reach out to us today for a free quote on our cost-efficient and timely translation services, interpreters, or other linguistic services.
Language Connections Inc.
2001 Beacon Street, Suite 105,
Boston, MA 02135
Phone: +1-617-731-3510
Email: service@languageconnections.com
