What to look for in a medical translation provider

When it comes to medical communications, pinpoint precision is crucial. Stakes are incredibly high. Unclear phrasings and the smallest of slip-ups can endanger patient safety, dent trust in your organisation and put paid to regulatory approvals. Whether you’re a medical device manufacturer, hospital or research institution, the choice of medical translation provider plays a central role in your risk management and communication strategies. Below, we outline some key aspects to help you make the right choice for you.

There is no denying that solicitors are knowledgeable professionals who can break down convoluted legalese with confidence, but you wouldn’t ask them to install a heating system or carry out heart surgery, would you? That’s because the legal, plumbing and surgical fields all differ greatly from one another, each demanding a specific skillset. This analogy also applies to the world of medical translation. To get the job done properly, you need a qualified translator who can navigate the complex terminology involved in healthcare, life sciences and clinical research.

If your content is subject to specific regulations, it’s also important that your translation provider knows their way around these regulatory frameworks. Take, for instance, pharmaceutical product documentation for submission to the European Medicines Agency (EMA). Such documents have to follow approved Quality Review Document (QRD) templates, which differ depending on the procedure chosen (centralised vs. decentralised) and whether the drug in question is intended for human or veterinary use. Covering all EU languages, the QRD comprise a summary of product characteristics (SmPC), patient information leaflet (PIL), and label. It’s important for the translator to adhere to the standard wording set out in these templates. Failure to do so can lead to unnecessary back-and-forth with the agency officials, delaying approvals and potentially pushing back your position in the competition. So even if a translation is of premium quality, if it doesn’t respect the QRD wording and formatting conventions, you might not get very far at all.

Whether it’s patient questionnaires for your clinical trials or packaging for your upcoming healthcare products, medical documents often contain highly sensitive data. It’s safe to assume that you therefore have strict security protocols in place to safeguard patient information and avoid leaking your latest pipeline innovations before they’re officially launched. To ensure end-to-end protection, you should expect the same of your translation provider. Trustworthy suppliers will ensure GDPR compliance, secure file transfer protocols and robust confidentiality agreements as standard.

In the medical field specifically, another choice you can make to help enhance quality is to opt for Linguistic Validation (LV). Linguistic Validation is an intricate, multi-layered process featuring multiple rounds of translation, back-translation and review by language specialists, patients and clinicians alike. When budgetary concerns are at play, clients can opt for a simpler two-step process of translation followed by revision of the target language content against the original source. This stripped-back variant of Linguistic Validation still adheres to the ISO 17100:2015 standard in line with what is sometimes referred to as the ‘four-eyes principle’.

Non-negotiable deadlines come with the territory of medical translation. One example our team regularly encounters comes following the adoption of a positive opinion from the EMA Committee for Medicinal Products for Human Use (CHMP). Here, marketing authorisation holders (MAHs) have a strict timeline of 5 calendar days after the CHMP opinion to submit their product information (PI) translations to Member State agencies. In other words, flexible capacity and reliability are crucial, as missing regulatory deadlines comes at great financial and reputational cost.

At the same time, you also need someone who is willing to advise you when it’s best to wait. Saying yes is easy. Giving a justified no to ensure quality is not compromised is harder. At First Edition Translations, our project managers will always give solid, transparent solutions. Supported by thousands of vetted linguists, we are in prime position to offer reliable delivery under urgency, yet we never jeopardise quality. If we think a project timeline could and should be extended on the basis of quality considerations, we openly advise our clients as such. Ultimately, the end result is as important to us as it is to you – and that’s exactly how it should be.

Medical translation is not merely a matter of language – it’s about precision, safety and trust. It is wise to consider the above-outlined points to find a translation agency that understands the stakes and delivers excellence. At First Edition Translations, we understand that medical translation requires a high level of expertise and pinpoint accuracy. We have amassed over 40 years of experience in the trade, working with a pool of highly skilled specialist translators covering most world languages. Whether you’re looking to launch a multinational marketing campaign or submit pharmaceutical documents in the 24 official EU languages, our project management team is always happy to discuss requirements under enquiries@firstedit.co.uk.