Our client GCP is a leading CRO that conducts clinical trials in different parts of the world. The trials are conducted in stages and they last years. We, as a preferred vendor, regularly translate different types of PILs, protocols and forms of informed consent.
We have been partners with our client for 5 years now. Generally, the language combinations we are asked to help with are English to Russian, English to Hebrew and English to Arabic.
We were tasked to translate and localize a text for a new device that will be used in the clinical procedures in several countries. In total, we needed to translate the text into 10 languages.
The new device had to go through regulatory approval in all 10 of these countries, so we created a plan how to perfect the translations in order to seamlessly meet those requirements.
We needed to translate the text for the software that the device was using, proofread the text to ensure the translation reflected the source text to the absolute maximum. When this step was completed, we needed to then involve a third party who performed a linguistic QA check, thus eliminating any probability for a linguistic issue with the translation.
Only after this was finalized, we could proceed with the localization of the text, and of course, last but not least, the QA testing of the software.
The new device had to comply with all regulatory requirements or it would simply not be released to the market. We understood that stakes were high and we were ready to jump in.
Due to the file format used to create the software we had to deal with over 100 separate files that required impeccable consistency among each other. This was definitely not the everyday project you might receive.
As this was a brand new device, there was no previously approved list of key terminology, which is an essential step in every translation project, no matter big or small.
The new device had to comply with all regulatory requirements
For this project we brought together a team consisting of highly specialized linguists that could cover the stages of translation, proofreading and linguistic QA and had previous experience specifically in translating and localizing software for medical purposes, thus ensuring the quality will meet our client’s expectations.
We took the time to create a precise terminology list based on the source files that was translated and revised before finally approved by the client.
We appointed a skilled Project Manager who was responsible for coordinating the tasks between all people involved and who kept the client informed of our progress.
Our QA specialists were the ones that meticulously handled the numerous tests done on the software to assure everything was but spotless.
Due to the file format used to create the software we had to deal with over 100 separate files.
We attested our capabilities once again when it comes down to innovative approach. Our client was impressed with the quality of the final files and how effortlessly it was for them to complete their project by the given deadline, no matter what challenges came in our way.
We were more than happy to hear that the device was later approved by the local authorities and it will be used to diagnose patients! We can confidently state that complex projects, such as this one, can truly strengthen the relationship between us and our clients.
ידע הוא כוח! הירשם לניוזלטר שלנו לקבל, מידע על שירותים, הנחות ועוד!