The Art and Science of Translating Regulated Content

To comply with laws and ensure that patients get the right treatment for their ailments, pharmaceutical, biotechnology and healthcare organizations must manage high volumes of content. They must keep all published information correct, current, and consistent across publications, packaging, websites and marketing materials. This is difficult enough to manage in just one language, but gets measurably more complicated as the companies add another step – translation into other languages. For each piece of content published in English, they now have to guarantee the accuracy, currency and consistency of the information they publish in French, German, Japanese, Russian, Thai and perhaps dozens of other languages.

Here are some tips from Welocalize Life Sciences for managing the art and science of translating regulated content.

  • Develop a clear global management strategy. Prepare the company and the products to compete in diverse international environments by aligning business goals with language, culture and communications characteristics. Appoint a qualified localization manager to oversee localization efforts.
  • Engage with partners who can help. Create and maintain processes for engaging and managing language and localization suppliers. Identify expert partners and technology platforms to help you efficiently translate and localize documents. Partner with industry providers like Welocalize Life Sciences who have specialist experience in regulated sectors and utilize only subject matter experts.
  • Consider language and culture. Regulated content may contain a variety of complicated medical terms that may not directly translate into another language. In addition, patients, whether inside or outside the home market, may have cultural values different from those of the researcher. Translation of clinical documents should take the specific culture into account. In many cultures, it is important that researchers and healthcare providers talk about the trial with – and possibly obtain permission from – the subject’s family. In some cases, organizations may need to gain permission from the local community before attempting to obtain consent from individuals for participation in a clinical trial.
  • Formalize your processes. Clearly document all processes connected with localization and use these processes to develop a system for efficient and effective localization. Centralizing translation and cultural adaptation processes often achieves consistency, correctness and legal compliance in global markets. This creates significant time and cost savings for your organization.
  • Leverage technology. If you manage content across multiple locations and translation providers, centralizing content management systems (CMS) and translation memory (TM) tools will streamline processes. Partnering with a language service provider who is willing and able to work across various technology platforms and provide guidance on how to optimize localization using technology is a critical part of a globalization strategy.
  • Conduct fluency checks. When medical and clinical materials are translated, it is not just accuracy but also fluency of the overall content that is required to ensure materials are culturally adapted for the target audience. Welocalize Life Sciences carries out a “fluency check,” after editing and proofreading, to ensure the flow of the compliance content is culturally appropriate and accurate. This ensures that consistency of terminology is maintained with no errors.

Cultural considerations, working with industry experts, and leveraging technology solutions are all key components of the translation process. Contact Welocalize Life Sciences for information on how we can help your global organization publish compliance materials and other regulated communications that are accurate and speak directly to your local, target audiences.

Language Barriers in End-of-Life Care

The population in the United States is growing older and more ethnically diverse over time, according to United States Census Bureau statistics. This means more medical resources will be devoted to end-of-life care (EoLC). Language barriers can often create additional costs and cause inefficiencies in EoLC. Studies show some patients from different ethnic groups are more likely to undergo intense, often non-urgent, treatments in their final years but are less likely to go into hospice care. end-of-life costs.

That’s a problem that better communication could ease, argues a team of researchers from the Stanford University School of Medicine and the Veterans Administration’s Palo Alto, California hospital. However, until recently, no one really knew what stood in the way of doctors talking with their patients about planning for their final days, especially when those patients were from different ethnic backgrounds.

A team of researchers, led by Stanford clinical professor and Veterans Health Administration Doctor Vyjeyanthi Periyakoil, has data from a study aimed at uncovering the stumbling blocks. Of the more than 1,200 doctors surveyed, about five in six reported having had significant difficulties talking about death and dying with patients from different ethnicities and as a group they cited language barriers as the top reason. (Read the full study: PLOS ONE.)

“Medical jargon is often difficult to translate into other languages [as equivalent words may not exist] and approximate translations do not convey the true meaning and may lead to misunderstandings and miscommunication,” Periyakoil and her team write. Doctors also cited families’ religious and cultural beliefs as barriers.

For any language team working on medical and healthcare translation and interpretation, they must be fluent, native linguists and hold a high level of subject matter expertise. It is important to keep the translated content aligned with the source content. There is no room for error. However, it remains important to adapt the content to resonate with local audiences, both culturally and linguistically. Putting translators, linguists, and reviewers into the shoes of the patient creates a deeper understanding of overall objectives which can be delivered into all locales.

Contact Welocalize Life Sciences for more information on our medical and healthcare translation services.

Welocalize Launches Dedicated Life Sciences Division

Frederick, Maryland – January 31, 2017 – Welocalize, global leader in innovative translation and localization solutions, announces the formation of Welocalize Life Sciences, a division that brings together the recent Welocalize acquisitions of Global Language Solutions (GLS) and Nova Language Services (Nova). The merged entities represent more than two decades of experience in specialized language services for clinical research, biotechnology, healthcare, medical devices, pharmaceutical companies and animal health. Read more

January 24-26, 2017: Summit for Clinical Ops Executives

Welocalize Life Sciences is an exhibitor at booth #517 at the 8th Annual Summit for Clinical Ops Executives (SCOPE), January 24-26, in Miami, FL.  SCOPE brings together over 1,500 clinical operations thought leaders and innovators for three-days of workshops, discussions and exhibits related to each aspect of clinical trial planning and management, including site selection, recruitment and retention, project management and post-marketing studies.

Welocalize Life Sciences Exhibits at SCOPE 2017

Frederick, Maryland – January 23, 2017 –Welocalize Life Sciences, a leader in specialized language services for life sciences and regulated industries, is an exhibitor at booth #517 at the 8th Annual Summit for Clinical Ops Executives (SCOPE), January 24-26, in Miami, FL.  SCOPE brings together over 1,500 clinical operations thought leaders and innovators for three-days of workshops, discussions and exhibits related to each aspect of clinical trial planning and management, including site selection, recruitment and retention, project management and post-marketing studies.

Read more

One-third of Hospitals in U.S. Fail to Offer Language Services

Twenty-four million people in the United States have limited English proficiency. They experience barriers to health care because of their inability to communicate effectively with providers.According to an analysis published recently in Health Affairs, more than a third of the hospitals in the United States in 2013 did not offer patients access to language assistance. In areas with the greatest need, about 25% of facilities failed to provide such services.Based on civil rights law, any hospital receiving federal funds must have language services available for its patients. However, many patients do not know their right to access language services.The study noted, private for-profit hospitals — the kind least likely to offer this kind of help — continue to grow in market share.But the challenge also provides an opportunity for hospitals to empower their customers to be informed patients.Read more about the study, LEP, and U.S. civil rights law in this article at Kaiser Health News .

For professional medical translation services, contact us.

Translation of PROs into 40 Languages for 50-Country Drug Trial

Welocalize Life Sciences provided specialized languages services to a Japanese company that specializes in multiple therapeutic areas, including psychiatric drugs. The client required translation of 10 patient instruments used to measure the effectiveness of the medication being tested into 40 languages for a 50-country drug trial. The client also wanted the translation validated through pilot testing on individuals via focus groups in 40 languages, in more than 20 countries. Read how the Welocalize Life Sciences team delivered on this large-scale project.

Delivering a Four-week ICF Translation Project in Five Days

Welocalize Life Sciences is uniquely qualified to support all of the multilingual initiatives for highly regulated industries. Our objective is to ensure that the language services we provide are accurate and submission ready, ensuring the most rapid time to market for products while mitigating risk. Read how the Welocalize Life Sciences team’s agility, ability to ramp up quickly and use of translation technology tools, turned a 51,000-word project in five business days.

Translation of Patient Retention Materials into 22 Languages

Welocalize Life Sciences was asked by a patient recruitment firm for the translation of multiple patient retention materials for multiple countries involved in a global clinical trial consisting of three protocols. Each country required a different set of patient retention materials, and each country had multiple sites that required site-specific customizations for the patient retention materials. Welocalize Life Sciences partnered with the patient recruitment firm to develop a customized process, ensuring that all translations were completed according to each country and each site’s specifications.

Why Racial Diversity in Clinical Trials Matters

Clinical trials provide a critical base of evidence for evaluating whether a medical product is effective before the product is approved for marketing. One challenge that remains is ensuring that research participants are representative of the patients who will use the medical product.In 2014, the Federal Drug Administration (FDA) released a report that called for, among other things, “identifying barriers to subgroup enrollment in clinical trials and employing strategies to encourage greater participation,” that was specifically aimed at underrepresented ethnic populations and women. Historically, the elderly, women (in some therapeutic areas), and racial/ethnic minorities have been underrepresented in trials. In response to these concerns, Congress included Section 907 in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, giving FDA direction to evaluate this issue and take action.An infographic published by Continuum Clinical shows examples of the massive health disparities among common disease states across different races and genders.
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According to the FDA, African Americans comprise 14% of the U.S. population, but only 5% of clinical trial participants. As the infographic above illustrates, African Americans account for a disproportionately high number of cases of cardiovascular disease and hypertension. Similarly, Hispanic/Latinos comprise 17% of the U.S. population, but less than 1% of clinical trial participants. Yet diseases such as obesity and Type 2 diabetes disproportionately affect Hispanic populations.Racial diversity in clinical studies matters because patients may respond differently to therapies based on their ethnicity or gender.For example, studies for a recently approved schizophrenia drug found that two important classes of blood pressure drugs were found to work less well in black/African American patients. The FDA has also reported labeling changes due to differences in dosing requirements between men and women, such as the recent labeling change with a sleep medication. As the  FDA’s Commissioner of Food and Drugs, Robert Cliff, stated in early 2016 when the FDA declared 2016 as the year of diversity in clinical trials, “These few examples show the importance of improving diversity in clinical trials, so medical products are safe and effective for everyone.”Welocalize Life Sciences specializes in linguistically and culturally accurate translation services for life sciences companies. Contact us for more information about our services for highly regulated industries.