The Missing Piece In Translating Clinical Research Materials

Mladen Stojak 1 month ago Comment

That dreadful phrase bad translation has two distinct meanings – first, there is the obvious one, a text (or any other material) replete with errors in meaning, style, grammar and orthography and second, the more serious one, including delayed and cancelled product launches, loss of time, resources and energy and, most dreadful of them all, negative representation on a foreign market, which is also the price of a bad translation.

How to prevent it?

Translating Clinical Research

Enter Language Solution

Let me tell you a secret that took me 15 years to figure out about providing top language services:

Translation is actually NOT what you are looking for.

What you really need is a language solution, which is essentially another name for an errorproof process in the language industry.

Now, you are probably wondering – “Why didn’t I know this before?”

Honestly – it’s not you, it the language solution market putting all the emphasis on translation, when in reality – if you work in heavily regulated industry like pharma, you need more than “just” a translation.

You need the “whole package” to make sure that the errors are avoided and the delivery is on time.

Why?

Because every error or missed deadline costs time, money, energy, affects reputation and compromises the overall quality of your product/service. Plain and simple.

So, what is the difference between “just” translation and language solution?

Translation remains the main part of the language solution, but it includes further services and procedures performed before, during and after the translation process. These services and procedures may vary depending on the specific project requirements, but they usually include:

  • Selection of the right linguist team for every project on the basis of their expertise, language pair and quality of their work;
  • Determining the scope and the requirements of each project;
  • Use of appropriate technology (Computer-assisted translation or CAT tools)
  • Development and use of appropriate translation assets (termbases and translation memories)
  • Professional human translation;
  • Professional human editing/proofreading of the translated materials by a second linguist team;
  • Subject-matter expert review (if required)
  • Computer-assisted quality assurance (QA) processing;
  • DTP and additional services (if required).

Life Sciences and Language

Where is the meeting point of localization – and other language services – and the pharmaceutical industry?

If we take a step back and look at medicines and medical devices as essentially products, it’s easy to see that translation and localization are the necessary tools for business operations on the global markets.

But if we remember that healthcare products are designed to improve the quality of life and health, it becomes instantly clear that development of language solutions for the life sciences sector requires specific approach, high expertise and rigorous quality control process.

Language Solutions for Clinical Research

Clinical research is one of the pivotal phases of development of pharmaceutical products in which companies test safety and efficacy of the new medications intended for human use.

It is performed in medical institutions and hospitals (clinical research centers) and involves wide groups of stakeholders, including the study participants, investigators and other healthcare professionals, ethics committee members and regulators.

With clinical research studies being increasingly outsourced, the need for localization of a wide range of study materials also increases.

These materials, inter alia, range from materials written by medical professionals for their peers, such as study protocols, requests for approvals and correspondence with local regulators, the materials composed by medical professionals for patients such as informed consent forms (ICFs) to patient-reported outcomes (PROs).

All clinical research materials are composed in a particular style, using a particular vocabulary and, in case of any regulatory-related content, the translated versions must follow the specific terminology and standards of the target markets and therefore the translation projects must be performed by the linguists who are familiar with the target market regulations, preferred/required terminology and the clinical research process in general.

This is where the strengths of an advanced translation/localization process truly come to the fore and the execution phase of that process begins with the selection of the most suitable linguists for the concerned language pair and professional domain.

Translated, proofread and approved segments of the translated materials are stored in the form of translation assets (terminology bases and translation memories) for further use that ultimately cut the translation costs down and, besides the standard quality control steps such as proofreading and computer-assisted quality assurance, function as an additional quality layer of quality assurance as the linguists perform every new translation project using the previously approved elements.

It’s All About Quality

The ultimate purpose of this is to deliver the translation of the best quality possible that answers the challenges of clinical research requirements, ultimately helping the life sciences companies close the regulatory cycles on the foreign markets and launch their products quicker.

What can you do right now if you are struggling with poor quality translation?

If you found this post helpful and need help with localization of clinical research materials, schedule a free translation process audit and I’ll tell you where the mistakes in your translation process are and how to correct them.

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