January 10, 2025 / by Margarita Núñez Estimated read time: 5 minutes
As a Contract Research Organization, you will need to outsource the translation of assets integral to any clinical project. Choosing an established and accredited medical translation company is crucial. Here are four points to consider:
1. Work only with ISO-certified language service providers
For you as a client, selecting a translation partner that is ISO 9001:2015 certified should ensure that you get consistent, good-quality products and services (and I add peace of mind)! You will also make your Auditor very happy since an ISO-certified company will tick all the boxes!
According to ISO: “ISO 9001:2015 sets out the criteria for a quality management system and is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement”.
Another important ISO certification is the ISO 17100:2015 certification, which focuses on the translation industry specifically, and it also provides:
“requirements for the core processes, resources, and other aspects necessary for the delivery of a quality translation service that meets applicable specifications”
In other words, it specifies how the translation process must be managed by all parties involved in a project, from initiation through final delivery. This includes the management of processes and resources, the qualification criteria for everyone involved, and any other elements required to ensure the delivery of a high-quality translation service.
Pro tip: Request copies of the latest ISO certifications from your LSP
2. Check translators’ qualifications
All your translations should be carried out by native, qualified, and experienced translators. I say 'native' because all translators should translate only into their mother tongue, and this is what is “common practice” in our industry.
I say 'qualified' because they must hold a degree or a similar third-level qualification to be a medical industry translator. And the qualification should be “relevant” to what they are translating: medical devices, veterinary, life sciences, pharma, etc. After all, quality is a basic expectation for the life sciences sector. And I say 'experienced' because they must have expertise in the domain, and expertise only comes with years of translating and learning.
Pro tip: Ask to see the translator's qualifications who will be working on your project.
3. Define a customized translation process to suit your projects
Forward and Back translation
Yes, that's right! For example, first translating the source (English) into the target (French) and then the target (French) back into the source (English) using different translators. Finally, comparing both English versions and resolving any “inconsistencies” or “mistranslations” between the French version and the English back translation.
If you think this is a mouthful, think again. There is the possibility of asking for two forward translations (by two different translators) and then choosing one to back translate… which depends on the CRO or their own clients' requirements. Everything is possible but costly.
Proofreading
Request a proofreading round (a third person) to proofread the final translations to ensure that the translation is correct. This is especially important for documentation, as the final PDF should be reviewed before it goes to the patient.
Certification
Ask for a “certification” at the end of the project to prove that your project has been translated using native, qualified translators in the medical domain.
Pro tip: Ask to see your localization process outline for your account.
4. Sign a non-disclosure agreement
You must ask the LSP to sign a NDA (Non-Disclosure Agreement) and even a MSA (Master Service Agreement) with a specific SLA (Service Level Agreement). That will ensure that all parties are under a "confidentiality agreement" and no information will be disclosed in the process of translation. A contract will also get you fixed pricing for a set number of years!
Any reputable LSP can easily offer you these four basic requirements. This is your safest option because you will receive certified translations and be assured of absolute confidence during the translation process.
So if you are not satisfied that your current LSP meets these criteria, consider evaluating a different Language Service Provider today!
