Recruit patients in any language
With MediLingua, keep your clinical trial documentation consistent and auditable across languages through our certified clinical trial translation services.
With MediLingua, keep your clinical trial documentation consistent and auditable across languages through our certified clinical trial translation services.
You should use one primary language for regulatory submissions as per the Clinical Trial Regulation (EU 536/2014).
You must translate materials into the languages of your subjects, then “back-translate” them to check for deviations.
You must use ISO-certified translations to file an application for regulatory approval with the FDA or EMA.
At MediLingua, we help CROs and pharmaceutical companies run multi-country clinical studies through 2 ISO-certified clinical trial translation services:
In multi-country trials, your original trial materials are often adapted to the language of in-country subjects and ethics committees. But this makes it difficult to keep track of who’s saying what. MediLingua offers clinical trial translation services in all the major languages to keep your documentation and stakeholders aligned across languages.
Sometimes in-country coordinators translate materials themselves. But do these translations align with your original materials? One way to check is a back translation. This time, MediLingua converts the translation back into your primary trial language. You can then detect deviations from your original materials and maintain alignment across your clinical trial.
We translate all the main trial documents. If you have another document in mind, get in touch and we’ll find a solution.
MediLingua is certified to ISO 9001 and ISO 17100. These certifications are the two stamps of approval that regulatory authorities look for, making our translations perfect for your regulatory submissions. Even so, we don’t believe in just meeting standards. We believe in surpassing them. That’s why we take our quality of translation even further.
We do medical and pharmaceutical translations only. Your clinical study documentation is safe in the hands of experts who’ve been doing this for nearly 30 years.
Our translations and back translations are certified to 2 international quality standards. Use them directly in submissions to regulatory authorities.
At MediLingua, we cover all major languages. No matter how many languages you’re juggling across your trial, MediLingua can help you lighten the load.
Ask questions and send documents through a single email address that is always monitored and never changes. No servers, no interfaces, no passwords.
With MediLingua, I’ve never seen a ball being dropped. And that is a huge thing in trials because we have so many balls in the air, and we have to make sure that so many things are happening. Just knowing that once I send a document to MediLingua, it will be picked up and it will go through the translation process and it will always come back – yeah, that's really a huge benefit.
Make your clinical trial documentation consistent and auditable across countries and languages.
At MediLingua, we help you recruit patients on every continent.
We’ve got answers! If you don’t find what you’re looking for, reach out to us directly.
We offer clinical trial translation services for all major languages in Europe, the Middle East, Asia, Africa, and the Americas. If you’re unsure about a particular language, just ask.
We can handle all kinds of file formats, from Word and InDesign to PowerPoint and Excel. However, we know that in the hustle and bustle of clinical trials, not everything will be available in the desired format. Tell us what you have and we’ll find a solution that works for everyone.
A translation adapts a document to the needs of a reader who speaks a different language. For instance, if you create an informed consent form in English but recruit patients in Spain, you must translate the informed consent form into Spanish.
A back translation checks the accuracy of a translation. In our example above, the Spanish translation of your English informed consent form is translated back into English. This new English translation is then checked against your original English informed consent form. Any meaningful differences between the two are reconciled. By back-translating, comparing and reconciling, we confirm the accuracy of your Spanish translation of the informed consent form.
We translate all the main trial documents: paper and electronic case report forms (CRFs and eCRFs), opinions and amendments for ethics committees, informed consent forms (ICFs), investigator’s brochures, patient information sheets (PISs) or leaflets (PILs), the protocol synopsis, quality of life (QoL) questionnaires, serious adverse event (SAE) reports, and study protocols. If you have another document in mind, get in touch and we’ll find a solution.
At MediLingua, our multi-step quality control process has been certified to ISO 9001:2015 and ISO 17100:2015. This guarantees the quality of the translations that we provide. It also means that you can use them directly in your submissions to regulatory authorities like the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
We also regularly engage with our peers and stay up to date on developments in our industry through our membership of the Globalization and Localization Association (GALA), European Union Association of Translation Companies (EUATC) and Netherlands Association of Interpreting and Translation Companies (VViN).
We are fully aware of the highly sensitive nature of the data in your clinical trial documentation. To keep your documents protected, we have our own SharePoint for uploading and downloading files securely. Our network is actively protected with a fully managed Unifi USG Pro firewall that includes systems to both detect and prevent intrusion. Our security logging is also actively monitored.
Additionally, all our translators sign a confidentiality agreement before working on your documents. If you want to know more about how we protect your documents and sensitive data, contact us.