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Author

Erica Manning

Erica Manning

Erica is the creative and language services manager at Imperial Clinical Research Services. She holds a JD from Michigan State University and is a licensed attorney in the state of Michigan. Erica joined Imperial in 2010 and during her tenure, she has overseen more than 1,600 graphic design and translation projects for global clinical research trials, primarily for patient recruitment and retention materials. She was involved in the development of Imperial’s translation services quality management system and certifications as a translation services provider. Erica is also a conference speaker and has spoken at numerous conferences including the Drug Information Association’s (DIA) annual meeting.

    Translation of Study Materials

    Clinical Trial Translation: Precision Is Key

    by Erica Manning May 9, 2023
    written by Erica Manning

    Accurate clinical trial translation services are key to the overall success of a study. Each participant needs to receive the same information in their native language to ensure consistent study messaging across all languages and accuracy to the protocol. I’ve compiled key translation best practices to consider when planning your global clinical trial and picking a translation vendor.

    Where are clinical studies being done?

    A good illustration showing the global nature of studies (and verifying the need for translations!) appears on clinicaltrials.gov. A healthy majority of studies listed there are non-U.S. only:

    A table from the World Health Organization (WHO) shows us where trials are taking place:

    Clearly, to reach our participants, we need to translate.

    Translation in general vs. clinical research translation

    Communicating with people in an understandable way is essential to clinical trial recruitment and retention, as well as participant safety and compliance throughout the study. It’s also a must according to some regulatory requirements.

    While regulations vary from one country to another, clinical trial documents and communications must be in a language the clinical trial participant knows. Translating clinical trial materials into the local language allows participants to understand what the trial involves, promotes their choice to join the study, and enables their ability to follow trial instructions.

    Because clinical trial materials are aligned with the protocol that has received regulatory approval, errors in translation can change the meaning of important content in study documents. This can cause protocol violations. Therefore, professional translators for clinical research need to have an excellent command of the language and they also need to have a medical/scientific background to understand medical terminology and the protocol.

    Translators must also understand the type of local clinical trial review process and the unique regulatory requirements for their region. And, finally, knowledge of local lingo is essential, so the participant materials are relevant and friendly to participants.

    Begin with a strong foundation for a smoother clinical trial translation process

    Creating source clinical trial content using the principles of plain language, which is communicating in a way your audience can understand the first time they read or hear it, fosters source materials likely to invoke comprehension and engagement for all literacy and educational levels.

    Also, thinking ahead and writing with translation in mind ensures the foundational text is unambiguous and easy to read. Improved source text makes it easier to translate. This saves time and money, avoids errors, and improves the readability of materials used for an international audience.

    Essential qualities in your clinical trial translation team

    To ensure you receive precise clinical trial translations, there are several qualities to look for when picking a translation vendor. First, make sure they have the expertise with all language pairs needed for your study. Next, the vendor should use qualified translators with life science experience. Translators should be selected based on their:

    • Source and target language proficiency
    • Educational and advanced training credentials
    • Professional experience and certifications

    Due diligence is important; assess their quality control processes to ensure they are robust. They should have:

    • A trained and experienced project management team
    • Effective standard operating procedures
    • Continual quality improvement
    • Strong document version control
    • Proven outcomes

    In addition, working with a translation vendor that adds value to the trial and collaborates with your in-country personnel (rather than just producing translation content as is) is a win-win for your trial and the participants. In-country clinical trial managers add valuable insight to the target-language content related to the specific study.

    Machine clinical trial translation

    Over the years, machine translation has advanced, thanks to technological developments. The latest phase of neural machine translation is proving to be the most promising, providing the most fluid and accurate translation results to date. But this technology is still emerging.

    As further data becomes available in more languages, machine learning will be able to produce more sophisticated outcomes. One challenge is to control the quality of the data used. Be sure to evaluate how a translation vendor utilizes this technology, control input quality, and check outcomes.

    While machine translation is cost-effective, especially for handling large documents, it can stumble when handling cultural nuances and is typically unable to recommend appropriate local deviations from the source content. Best practices encourage human oversight of the outcomes at this time to ensure machine translations are accurate and patient-friendly.

    There also remains a challenge of execution – we must not use machine translation as an incentive to accept substandard outputs to increase volume and keep costs low. (The money over quality dilemma exists everywhere and the clinical trials industry is no exception). However, as technology progresses, machine translation is likely to become an increasingly useful tool for clinical trial materials.

    Imperial advantage

    Imperial specializes in translation services for the global life-science industry — from the world’s largest pharmaceutical companies and CROs to major health care organizations.

    We provide:

    • Global network of fully credentialed in-country linguists in over 100 languages
      • Subject matter expertise
      • Demonstrated history of success
    • Quality process
      • Certified quality management system to the ISO 9001:2015 standard by Intertek
      • Demonstrated outcomes
        • Strong document version control
        • Notarized translation certificates
        • Meets IRB/EC requirements
      • Experienced, multilingual project management team
        • Mitigates common pitfalls
        • Coordinates with in-country trial managers to incorporate their insight
      • Print-ready desktop publishing (DTP)/formatting

    Imperial is a proven leader in the development, translation, print production, and global delivery of clinical trial materials. Contact us for your clinical trial translation needs and to find out about our other stellar clinical trial services!

    May 9, 2023 0 comment
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  • Business InsightsPatient Recruitment and Retention

    Artificial Intelligence for Clinical Trials: Move Ahead, or Halt?

    by Erica Manning July 26, 2022
    by Erica Manning July 26, 2022

    This blog was featured on Clinical Trial AI Weekly. For centuries, science fiction writers have toyed with the endless possibilities of artificial intelligence (AI). And now we’re living the future those writers celebrated and also feared. How might AI apply in the realities of our…

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  • Business Insights

    3 Surefire Ways Clinical Trial PMs Can Tame Their Inbox

    by Erica Manning March 15, 2022
    by Erica Manning March 15, 2022

    Email is a great thing: it allows busy clinical trial project managers to juggle multiple schedules, protocols, and teams in different time zones all over the world and still keep projects moving. Email chains keep a repository of time-stamped information and show documentation of discussions…

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  • Translation of Study Materials

    Better Instead of Worse: 3 Tips for Managing Translation Document Review

    by Erica Manning August 24, 2021
    by Erica Manning August 24, 2021

    The documents we create for clinical trials are collections of words. Reviewing these documents can be a straightforward process, with the final draft approved after one or two rounds of changes. In clinical trial translation management, sometimes a document is improved by the edits, sometimes…

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  • Site Materials & Logistics

    How to Take the Pain Out of Study Archiving

    by Erica Manning March 8, 2021
    by Erica Manning March 8, 2021

    Research record retention requirements, including the length of time files must be retained, are mandated by FDA regulations, ICH guidelines, non-U.S. regulatory agencies, and the sponsoring company’s SOPs. After a study closes, retention requirements are minimally two years but often exceed 15-30 years. The common requirements for storage of research patient case histories and essential documents (TMF) include:  Continual secure protection with limited access…

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  • Translation of Study Materials

    Keep Mother Languages Alive!

    by Erica Manning February 23, 2021
    by Erica Manning February 23, 2021

    Many people take their language skills for granted (even if it is just one). Mother tongue is the language or dialect a person is first exposed to and may also be considered the language or dialect of a person’s ethnic group. Language allows us human…

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  • Business InsightsClinical Trial Writing and Design

    Process & Personalities: Tips for Clinical Trial PMs Working With Designers

    by Erica Manning February 21, 2019
    by Erica Manning February 21, 2019

    Working on a clinical trial creative design project with graphic designers can feel challenging. Typically, careers in clinical trial project management or operations attract a different personality type than people who are attracted to artistic fields. Differences in communication style and work environment preferences can…

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  • Clinical Trial Writing and Design

    Your Clinical Trial Branding Project: Questions to Ask Before Starting

    by Erica Manning January 9, 2019
    by Erica Manning January 9, 2019

    In this blog, we’ll discuss the best strategies for planning ahead before starting your clinical trial branding initiative. Planning ahead is important for any project but especially for creative ones. Here are tips to help get your branding project started off right: Define your audience…

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  • Business InsightsClinical Trial Writing and Design

    4 Tips for Writing for Patients in Clinical Trials

    by Erica Manning June 13, 2018
    by Erica Manning June 13, 2018

    Writing for patients can be tricky. Now, layer in the unique challenges of those participating in clinical research trials. Intimidated? Don’t be. By sticking to a few parameters, you can write content for clinical trial participants that is purposeful, engaging, and doesn’t cause a compliance…

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  • Business InsightsClinical Trial Writing and Design

    Writing Clinical Trial Content by Committee: Getting Everyone on the Same Page

    by Erica Manning May 31, 2018
    by Erica Manning May 31, 2018

    The more the merrier? Sure, there are many times when that holds true, but not when it comes to having multiple players contribute to writing clinical trial content. Do you sometimes feel like your documents are constantly stuck in the review process? You are likely…

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