With MediLingua, keep your clinical trial documentation consistent and auditable across languages with regulatory-ready clinical trial translation services for CROs and pharmaceutical companies.
Multi-country clinical trials present numerous challenges. The EU Clinical Trial Regulation means you must use one primary language for regulatory submissions. But then you must translate your trial materials into the languages of your subjects, and “back-translate” them to check for deviations.
And on top of that, you can only use ISO-certified translations to file an application for regulatory approval with the FDA or EMA.
Luckily for you, this is where we come in.
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.
MediLingua is certified to ISO 9001 and ISO 17100, so we can give you a translation certificate to prove the authenticity of your translation and speed up the approval of your submissions.
MediLingua offers clinical trial translation services in all the major languages so that you can keep track of who’s saying what and communicate consistently across sites and trial countries.
Our experts focus on medical and pharmaceutical translations only to produce accurate, culturally appropriate translations of your clinical trial documents.
Our translations and back translations are certified to 2 international quality standards, so you can use them directly with your 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.
We’ve got answers! If you don’t find what you’re looking for, reach out to us directly.
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 you.
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 we can issue a translation certificate on final delivery. This proves the traceability and authenticity of the clinical trial translation, so you are free to use it directly in your submissions to regulatory authorities like the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
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 server for uploading and downloading files securely. Our network is actively protected with a fully managed 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.