SimulTrans Localization Blog: SimulTips

Contract Research Organizations: Selecting your Translation Partner

[fa icon="calendar"] May 17, 2016 / by Margarita Núñez

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CRO (Contract Research Organization) is a service provider to the pharmaceutical, biotechnology, and medical device industries. They offer a range of services on a contract basis. The advantage for clients of CROs is that they do not have to invest in and maintain a team for these services (including translation) which is rather costly.

 

The CRO will need to outsource the translation of a number of assets integral to any project, for instance, a clinical trial prior to submitting to the different bodies in each country for approval: from case report forms, informed consents, surveys, questionnaires, reports, patient information, patient reported outcomes, subject information, and GP letters; to the localization of software devices and any supporting operating manuals.

Choosing an established and accredited translation company is a crucial part of this service offering, after all your client relies on you and you on your translation company…

So what criteria should you consider to find the perfect translation services partner?


1. Work only with ISO Certified Language Service Providers

 

ISO 9001:2015
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”. For you as a client, selecting a LSP 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!

ISO 17100:2015
This certification 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” (more peace of mind here)!

In other words, it spells out how the translation process will have to be handled by all parties involved in the translation of a project and the delivery of the project. For instance, the management of the processes and the resources, the qualification requirements, and any other items necessary for the delivery of a quality translation service.

Request copies of the latest ISO certifications forms 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 it is “common practice” in our industry.

I say 'qualified' because they must hold a degree or similar third level qualification in order to be a translator for the medical industry. And the qualification should be “relevant” for what they are translating: medical devices, veterinary, life sciences, pharma, etc.

After all, quality is a basic expectation for the life sciences sector. I say 'experienced', because they must have expertise in the domain and expertise only comes with years of translating and learning.

Ask to see the Translators’ 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… that 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.
Ask to see your localization process outline for your account!


4. Sign an NDA
It is imperative that you 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, and this is your safest option because you will receive certified translations and be assured of absolute confidentially during the translation process.
So if you are not satisfied that your current LSP meets these criteria, consider the implications.

Evaluate a different Language Service Provider today!

Click for a Complimentary Translation Project

Topics: Medical Translation

Margarita Núñez

Written by Margarita Núñez

Margarita is SimulTrans' Director, Global Marketing. She spearheads SimulTrans' Digital Marketing Strategy by creating, managing, and publishing content for inbound and outbound campaigns across multiple channels. Margarita has more than 25 years of experience in sales and management for the localization industry. She has been involved in many localization organizations, currently serving as a Program Director for Membership for Women in Localization, a non-profit global organization.