Pharmaceuticals Archives - Terra Translations https://terratranslations.com/tag/pharmaceuticals/ Your English and Spanish language solution Thu, 08 May 2025 15:08:33 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 https://terratranslations.com/wp-content/uploads/2021/11/cropped-250X250-32x32.png Pharmaceuticals Archives - Terra Translations https://terratranslations.com/tag/pharmaceuticals/ 32 32 198841761 Understanding Key Challenges in Pharmaceutical Translation https://terratranslations.com/2025/02/04/challenges-pharmaceutical-translation/ https://terratranslations.com/2025/02/04/challenges-pharmaceutical-translation/#respond Tue, 04 Feb 2025 11:00:00 +0000 https://terratranslations.com/?p=24548 Pharmaceutical translation is uniquely complex work that requires a precise blend of skills including linguistic expertise, medical knowledge, and cultural awareness. Practitioners must also be adept at navigating significant hurdles to ensure clarity and compliance in their translations. Below, we explore several of these challenges and how they are addressed in order to meet industry demands.

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Pharmaceutical translation is uniquely complex work that requires a precise blend of skills including linguistic expertise, medical knowledge, and cultural awareness. Practitioners must also be adept at navigating significant hurdles to ensure clarity and compliance in their translations. Below, we explore several of these challenges and how they are addressed in order to meet industry demands.

Handling Complex Terminology and Medical Jargon 

One of the most significant responsibilities in pharmaceutical translation work is the proper handling of intricate medical terminology. With roots in Greek, Latin, and modern science, pharmaceutical language is complex and full of abbreviations, acronyms, and specialized phrases. As they work across cultures and languages, translators must ensure these terms remain clear, accurate, and aligned with international regulatory standards, such as those issued by the World Health Organization. When terms lack direct equivalents in target languages, linguistic creativity and medical expertise become essential to preventing misinterpretations that could impact patient care

Addressing Diverse Audiences 

Pharmaceutical content can target vastly different audiences, meaning translators must be prepared to pivot their tone and style accordingly. Patient-facing materials, such as informational brochures, must use accessible, everyday language to guide audience understanding. Professional-facing content, which might include clinical trial reports or regulatory submissions, requires precise, technical terminology for its researcher, physician, and institutional audiences. When a linguist successfully adjusts tone, complexity, and style, they must also ensure the content remains accurate and appropriate in the target language. 

Mastering a Variety of Document Types 

Language experts working in the pharmaceutical sector must have mastery over a wide range of document types and their respective requirements. Common document examples include: 

  • Regulatory submissions: Complex informational forms required for product approval. 
  • Clinical trial protocols and reports: Detailed, data-heavy materials for scientific analysis. 
  • Safety data sheets: Guidelines for the proper handling and storage of pharmaceuticals. 

Each document presents unique linguistic and formatting challenges that demand technical knowledge and precision to meet industry expectations. 

Meeting Pharma Demands 

The pharmaceutical industry relies on highly specific language and procedures in its operations—and therefore, so must linguists who specialize in this sector. In addition, regulatory bodies may impose stringent and sometimes-unusual requirements that specialized translators must navigate. These requirements often include: 

  • an understanding of country-specific terminology and phrasing standards 
  • adherence to strict formatting rules, such as specific templates or file types 
  • the provision of certified or notarized translations for compliance purposes 

Staying informed about changing regulations and building expertise in these areas helps linguists meet expectations and ensure that their work supports product approval processes. 

Embracing Cultural Sensitivity 

Cultural differences in pharmaceutical practices and patient expectations make it crucial for translators to adapt language in a way that is both accurate and culturally appropriate. Strong cultural awareness allows linguists to make adjustments that enhance patient comfort and comprehension, which fosters an experience that is respectful of individual preferences and needs. For instance, a translator might point out that in cultures with a history of distrust in healthcare systems, terms like “clinical trial” or “experimental treatment” could evoke fear or suspicion in patients. In such cases, it would be essential to adapt these terms to more neutral, reassuring alternatives, like “health study” or “research-based treatment.” 

Balancing Time Sensitivity and Quality 

Pharmaceutical translation projects are often time-sensitive due to their impact on patient care and product releases. Translators in this field must be prepared to deliver high-quality renderings quickly, but always be mindful of balancing speed with accuracy. Timely and precise translations help ensure patient safety and keep pharmaceutical companies on schedule for product launches. 

Conclusion  

Overcoming the challenges posed by pharmaceutical translation requires a combination of linguistic expertise, technical precision, and cultural awareness. Translators play a critical role in bridging communication gaps, ensuring clear and compliant content, and ultimately, supporting global healthcare efforts. As they navigate the field’s complexities, they help deliver accurate, accessible information to diverse audiences, there by improving patient safety and advancing the reach of pharmaceutical innovation.

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The Three Pillars of Sustainability: How the Pharma Industry Leads the Charge https://terratranslations.com/2025/01/01/pillars-sustainability-pharma-industry/ https://terratranslations.com/2025/01/01/pillars-sustainability-pharma-industry/#respond Wed, 01 Jan 2025 11:00:00 +0000 https://terratranslations.com/?p=24310 In today’s world, sustainability has become an essential priority across industries, pushing businesses to consider their impact on the planet and society. At Terra, we’re honored to work closely with this sector and have seen firsthand the impressive strides companies are making toward a sustainable future. 

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In today’s world, sustainability has become an essential priority across industries, pushing businesses to consider their impact on the planet and society. Companies from different fields are stepping up to lead the change, but we want to turn our attention to the pharmaceutical industry. At Terra, we’re honored to work closely with this sector and have seen firsthand the impressive strides companies are making toward a sustainable future. 

Environmental, Social, and Governance (ESG) are the three foundational pillars of a sustainability-focused strategy. In this context: 

  1. Environmental focuses on reducing ecological impacts and sustainability, such as lowering CO2 emissions and conserving resources. 
  1. Social considers issues like working conditions, human rights, and inclusivity
  1. Governance emphasizes transparency, ethical business practices, and responsible management. 

An ESG strategy provides a structured approach to guide companies toward meaningful sustainability goals by aligning their operations with these pillars, which contribute to both industry progress and environmental responsibility. 

How the Pharmaceutical Industry is Driving Change

Pharmaceutical companies are embracing innovative ESG strategies to reduce their environmental footprint and promote social equity. Here are some ways they’re achieving significant goals: 

  • Novo Nordisk is working toward zero environmental impact by building sustainable healthcare systems through partnerships with governments, NGOs, businesses, and communities. Their focus on “Access & Affordability” underscores the importance of healthcare that is both sustainable and accessible
  • Pfizer is taking action to reduce operational waste, conserve resources, and prioritize environmental sustainability as a means of mitigating climate risks. They aim for net-zero emissions, recognizing the direct link between climate change and human health. 
  • Johnson & Johnson is pushing for renewable energy across their operations. Their commitment includes creating sustainable products and promoting environmental health equity. 
  • Haleon has integrated a sustainability impact assessment tool into all innovation projects. Their transparent reporting, including a website carbon indicator, highlights their dedication to responsible environmental stewardship

These companies set an example, not only for others in the pharmaceutical industry but for their entire supply chain, encouraging all stakeholders to prioritize sustainability. 

Towards a Greener Tomorrow

The dedication of these pharmaceutical leaders is setting a strong precedent, fostering a ripple effect that reaches their partners and suppliers. At Terra, we’re committed to supporting this transformative journey by implementing our own sustainable initiatives every year. Together with our partners, we aim to champion a greener, more responsible industry. 

Conclusion

As sustainability becomes increasingly critical, we’re confident that more pharmaceutical companies will follow suit. This ongoing commitment to innovation and environmental responsibility will benefit our planet and future generations. It’s a journey that requires continuous improvement and collective effort, and we encourage all industries to embrace the challenge. 

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Healthcare vs. Pharmaceutical Translation: Understanding Key Differences https://terratranslations.com/2024/11/11/healthcare-vs-pharmaceutical-translation-key-differences/ https://terratranslations.com/2024/11/11/healthcare-vs-pharmaceutical-translation-key-differences/#respond Mon, 11 Nov 2024 12:41:37 +0000 https://terratranslations.com/?p=24252 In the closely connected fields of healthcare and pharmaceuticals, translation plays a vital role in bridging language gaps. Though these industries may appear similar, their translation needs differ significantly—which affects patients, professionals, and translators alike.

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In the closely connected fields of healthcare and pharmaceuticals, translation plays a vital role in bridging language gaps. Though these industries may appear similar, their translation needs differ significantly—which affects patients, professionals, and translators alike. Understanding these distinctions is crucial for delivering accurate information to diverse audiences, from patients needing accessible health information to professionals requiring highly specialized content. 

Industry Focus 

In the healthcare field, translation aims to improve communication between healthcare providers and patients. Since much of the content is patient-facing, it must be easy for individuals from various linguistic and cultural backgrounds to understand. Healthcare translation includes materials like patient handbooks, public health brochures, and hospital signage—all of which must be clear and accessible to support comprehension and foster trust. This type of translation directly impacts patient outcomes, as even small misunderstandings could lead to adverse health effects. 

Pharmaceutical translations, however, are focused on supporting drug development and regulatory compliance. This content is primarily intended for professionals—such as doctors, researchers, and regulators—requiring highly specialized scientific language. Here, accuracy is paramount to maintain the integrity of drug formulations, clinical studies, and research documentation. Any errors could have significant consequences, such as regulatory rejections or potential legal issues, making precision a top priority. When it comes to marketing campaigns and more creative content, the target audience is usually patients, and therefore the translation must be crafted with this in mind. 

Terminological Accuracy vs. Cultural Adaptation 

In healthcare translation, cultural adaptation is essential. Translators must consider local beliefs, healthcare practices, and cultural nuances to make information resonate with diverse patients. This adaptation is particularly important to build trust and ensure patient comprehension, as an overly literal translation could confuse or mislead patients and impact their health and quality of life. 

While cultural adaptation is often used in marketing content, pharmaceutical translation prioritizes terminological accuracy. This is critical for preserving the meaning of highly technical documents, such as dosage instructions and clinical trial results. Pharmaceutical translators must adhere strictly to scientific terminology, as even a minor error could compromise drug safety or lead to regulatory complications. In this context, precision in language is essential to protect product integrity and patient outcomes. 

Types of Content for Translation 

Healthcare translation typically covers accessible documents like patient handbooks, public health brochures, and informational signage. These materials must use clear, straightforward language to ensure they are easily understood by a wide audience, including those without medical knowledge. Translators must consider simplicity and clarity above all to ensure that patients understand crucial health information. 

Pharmaceutical translation involves highly specialized content, including clinical study reports, regulatory submissions, and product leaflets. Translators must have expertise in both medical and regulatory language to meet the stringent standards required by regulatory authorities across different countries. Inaccuracies in this type of translation could not only pose legal risks, but also jeopardize patient safety on a global scale. 

Global Impact 

Localization is particularly important in healthcare, where hospitals and clinics often serve multilingual populations. By translating healthcare materials into multiple languages, providers can offer more inclusive care. 

Pharmaceuticals, generally, operate on a global scale. Medications are often produced in one region and distributed worldwide, making consistent, accurate translation essential. Translating instructions, safety guidelines, and disclaimers effectively across regions ensures that the global public has access to safe and reliable products. 

The Takeaway 

While healthcare and pharmaceutical translation serve distinct roles, both are crucial in enhancing health and safety globally. Healthcare translations prioritize cultural relevance and clarity, while pharmaceutical translations emphasize terminological accuracy and compliance. Collaborating with professional translators helps enhance both sectors by ensuring critical information crosses linguistic barriers effectively.

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Nurturing a Culture of Compliance: Terra’s Journey and Approach  https://terratranslations.com/2024/06/11/culture-compliance-terras-journey/ https://terratranslations.com/2024/06/11/culture-compliance-terras-journey/#respond Tue, 11 Jun 2024 10:00:00 +0000 https://terratranslations.com/?p=23164 A culture of compliance encompasses a set of values, behaviors, and attitudes guiding individuals within an organization to adhere to policies, procedures, and regulations. Read on to learn more about how we nurture compliance culture at Terra. 

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A culture of compliance encompasses a set of values, behaviors, and attitudes guiding individuals within an organization to adhere to policies, procedures, and regulations. This framework facilitates better decision-making at all levels, ensuring alignment with the business’s rules. 

At Terra, our commitment to fostering a culture of compliance goes beyond mere adherence to standards. We emphasize cultivating a sense of belonging and shared purpose among team members. Our dedication to continuous improvement stems from the firm belief that there is always room for enhancement, presenting opportunities for growth and innovation. 

This commitment to compliance is evident in our ISO-certified services maintained since 2019 and our strict adherence to HIPAA regulations. Read on to learn more about how we nurture compliance culture at Terra.  

ISO Certifications 

We strive to select certifications that truly enhance our operations and client services. The ISO 9001 and 17100 standards drive our quality-oriented translation services

To maintain these certifications through the years, we develop structured training programs and strategic initiatives to provide each team member with the latest tools and encourage them to embrace new technologies. Throughout this process, we constantly review our procedures. Thanks to these efforts, our team members understand their pivotal role in our quality management system and diligently apply best practices in their daily tasks. 

HIPAA Compliance 

As a language service provider, we have a strong commitment to language access. However, we understand that in the healthcare space specifically, a lot of sensitive and confidential information is shared in the translation projects our client entrusts us. As such, we need to handle these files with the utmost care. The compliance culture we first cultivated among our team with ISO allowed us to pursue HIPAA compliance with confidence. Every individual handling ePHI projects understands the importance of safeguarding this information, shares these values, and does everything in their power to uphold them. 

Compliance is a Team Effort 

If a compliance issue arises, the focus becomes identifying the root cause of the problem—not the person responsible for it. During non-conformity analyses, individuals from diverse company teams work together to examine deviations, gain a deeper comprehension of the origin of the problem, and collectively devise solutions. 

While compliance is mainly an internal process, external validation is essential to maintain our clients’ trust. Terra hires experienced external auditors to conduct comprehensive reviews. These internal audits are invaluable learning experiences, where team members see firsthand the impact their compliance efforts have on the team results. This independent evaluation leaves no room for improvisation. At the same time, it enables us to identify areas for improvement in our processes. 

The Takeaway 

Fostering a culture of compliance isn’t easy, but organizations that prioritize it set themselves up for long-term success. At Terra, we navigate the path to continuous improvement with a compass of transparency, collaboration, and an unwavering commitment to excellence.

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The Role of Cybersecurity in HIPAA-Compliant Translation Services https://terratranslations.com/2024/05/21/cybersecurity-hipaa-compliant-translation-services/ https://terratranslations.com/2024/05/21/cybersecurity-hipaa-compliant-translation-services/#respond Tue, 21 May 2024 10:00:00 +0000 https://terratranslations.com/?p=22817 Robust cybersecurity is crucial to protect individuals from evolving threats and safeguard the integrity of sensitive health information.  Let’s take a closer look at the role of cybersecurity in HIPAA-compliant translation services.

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As healthcare cyberattacks surge, cybersecurity is paramount. A 60% year-over-year rise, affecting over 40 million individual patients’ data in 2023, highlights the growing complexity and harm. Robust cybersecurity is crucial to protect individuals from evolving threats and safeguard the integrity of sensitive health information. 

Let’s take a closer look at the role of cybersecurity in HIPAA-compliant translation services.  

Building a Strong Defense  

Terra is a language service provider (LSP) that handles the translation of very sensitive information, as such, we understand that cybersecurity is imperative. These are some of the measures we have in place to build a strong defense:  

  • Proper monitoring. All electronic devices owned by Terra are monitored through Microsoft Azure tools, which detect potential threats. Our translation management system tracks all log activities for projects, generating a distinct timestamped record on projects with ePHI
  • Secure on-premises servers. We have our own secure on-premises server in Milwaukee, Wisconsin, which ensures that the data stays within our safe environments. This also gives us more control over information management in real-time and on demand. 
  • Unique logins. Everyone with access to ePHI has a unique login and strong password—which is frequently updated for additional security.  
  • Microsoft Defender for Endpoint. Terra utilizes this program to ensure security through MFA for all Active Directory users.  

An Ongoing Commitment to Improving Cybersecurity  

There are some other steps the Terra team takes to continue to improve our cybersecurity efforts: 

  • Continuous risk assessment. Terra executes risk assessments on a yearly basis under the most stringent guidelines and practices to preserve the security of all private information entrusted to us. During this assessment, our processes are audited by an external consultant specialized in HIPAA compliance and IT security. Their recommendations are then implemented so our processes, protocols and software comply with the latest regulations and stay at the cutting edge in terms of cybersecurity. 
  • Security protocols. Our routers actively track and log all attempted security breaches. We conduct regular evaluations to detect any unusual behavior in our processes. 
  • Data protection measures. Our IT department explores new advanced technologies to strengthen security and implement robust backup and recovery plans for ePHI integrity during emergencies or system failures. 
  • Fostering a culture of compliance. Our team regularly trains to uphold our commitment to safeguarding sensitive information. Continuous collaboration with the IT department and our Privacy Officer allows each team member to play a vital role in compliance. 

Cybersecurity beyond healthcare 

Terra places the highest importance on maintaining robust cybersecurity measures and not just because of HIPAA compliance. In the language services industry, all sorts of confidential and sensitive information are handled in a digital format that is usually shared electronically.  

“In the healthcare field, it could be a medical record that would really hurt people if it were made public. But at the same time, in our other verticals, we handle court statements, sometimes from extremely dramatic situations, that no one would want to see disclosed. In other sectors, the damage can be just economic, but it can be huge and disrupt industries,” Dr. Matías Giannoni, Ph.D. and Privacy Officer at Terra explained.  

The takeaway 

The imperative role of cybersecurity in ensuring HIPAA compliance cannot be overstated for LSPs. As technology bridges geographical gaps and facilitates the global exchange of information, the responsibility to safeguard sensitive patient data becomes paramount. Terra’s Privacy Officer, in conjunction with our vigilant IT Department, plays a pivotal role in fortifying cybersecurity measures not just as a regulatory requirement but as a fundamental pillar in safeguarding privacy, maintaining confidentiality, and preventing potential harm to the different industries we work with. 

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Thriving Together: The Impact of Company Culture at Terra  https://terratranslations.com/2024/04/16/company-culture-terra/ https://terratranslations.com/2024/04/16/company-culture-terra/#respond Tue, 16 Apr 2024 10:00:00 +0000 https://terratranslations.com/?p=22911 Having a strong company culture helps businesses retain the best talent, increases productivity, and improves employee happiness. Let’s explore what organizational or company culture is, why it is important to cultivate a good culture.

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Having a strong company culture—also known as corporate culture or organizational culture—helps businesses retain the best talent, increases productivity, and improves employee happiness. Let’s explore what organizational or company culture is, why it is important to cultivate a good culture, and what benefits it can bring in the long run for organizations that prioritize it.  

What is “organizational culture” and why is it important? 

The term “organizational culture” is often discussed in business, but a clear definition is hard to pin down. It comes from social anthropology and includes the knowledge and beliefs people acquire in society. In the 1970s, this term became crucial for meeting the needs and values of workers. Today, companies value it more than physical assets, using it to shape new strategies.  

Since we spend over half our day working and interacting with colleagues, a positive organizational culture significantly impacts our well-being and satisfaction in both professional and personal aspects of life. At Terra, we focus on building a strong company culture, recognizing its importance in our success. 

Company Culture at Terra 

Being a 100% virtual company since its inception in 2000, Terra has always prioritized creating opportunities for connection and support amongst our team despite the lack of face-to-face interactions. We understand the importance of fostering a sense of companionship and collaboration, especially in a remote setting where traditional avenues for communication are often limited.  

To address these challenges, we implement various strategies such as prioritizing phone over email communication, hosting monthly company-wide meetings led by our leaders to discuss business updates and vision, team-specific monthly meetings with our CEO, and weekly check-ins within each team for progress updates. Additionally, we provide recreational spaces and flexibility to ensure a well-rounded and fulfilling work experience for our team members. 

Impact on retention 

Within each team, microcultures inevitably form, even within the broader organizational culture defined by the company’s mission and values. These microcultures develop unique values and work styles. While these microcultures need to maintain respectful and functional dynamics that align with the company’s overall objectives, it’s equally crucial to respect their individuality.  

Numerous studies demonstrate that factors beyond compensation influence an individual’s decision to remain with a company. Therefore, acknowledging and respecting the unique microcultures within teams contributes significantly to employee retention and overall organizational success.  

Thanks to these efforts, Terra currently boasts a remarkable 95% retention rate. Positive feedback from climate surveys underscores the effectiveness of our approach, demonstrating that employees continue to choose Terra not only for the supportive team environment but also for the career challenges it offers and the growth opportunities it provides for every collaborator. 

The takeaway 

Finding and training the right talent takes a lot of work and money. To retain top talent, you need to prioritize building a strong company culture that reflects shared values amongst your workforce. Doing so will help both the organization as a whole and individual team members thrive.

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Brazil as an emerging market: Key industries https://terratranslations.com/2022/07/22/brazil-as-an-emerging-market/ https://terratranslations.com/2022/07/22/brazil-as-an-emerging-market/#respond Fri, 22 Jul 2022 13:47:00 +0000 https://terratranslations.com/web/?p=15379 The Brazilian market provides nearly endless business opportunities thanks to its massive population of more than 211 million residents. Let’s examine why these industries can benefit so much by properly entering this vibrant market. 

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The Brazilian market provides nearly endless business opportunities thanks to its massive population of more than 211 million residents. While many different types of businesses across multiple industries have the chance to thrive in this market, the video game, e-learning, and healthcare and pharmaceutical industries in particular have a lot to gain by entering and embracing the Brazilian market. Let’s examine why these industries can benefit so much by properly entering this vibrant market. 

Video Games

Because only 5% of the Brazilian population speaks English, localization into Portuguese is a must if you want your video game to be widely accessible to Brazilians. It’s extremely important that you localize your video game for the Brazilian market. Especially when you consider the fact that this country is home to over 66 million gamers, which is almost as many people that make up the entire UK population. An important factor to understand about the Brazilian market is how much they rely on their mobile devices because of how much they rely on their mobile devices, in part due to long commutes on public transport and affordability when compared to other platforms. Localizing mobile games in particular should be a priority for video game creators

E-Learning

Those that focus on the corporate training sector in particular have great potential to break into this market right now. Because only a minority of people in Brazil speak English, this language barrier prevents them from taking online courses that are not in their native language. Data suggests that Brazilian industries are developing fast, but their workforce is not adequately trained and can lack specific skills. If you adapt your online courses to their native language, you can help address this need and expand your reach in this market. 

You also have the opportunity to adapt your e-learning courses to a mobile format, which will appeal to this unique market. By 2023, the Latin America e-learning market is anticipated to generate more than $3 billion in revenue, so this is not an opportunity that e-learning content creators want to sleep on. 

Healthcare and Pharmaceuticals

Circling back to those 211 million Brazilians, that’s a lot of people who need access to translated and localized healthcare and pharmaceutical information. As of 2018, there were more than 250 health-focused startups in Brazil. This isn’t surprising when you consider that Brazil is the world’s seventh-largest health market. 

From prescription packaging to medical records to insurance claims, there is a great need for proper translation and localization in the Brazilian healthcare industry. Brazil’s pharmaceutical market in particular is one of the largest in the industry and rapidly growing. With many pharmaceuticals developed in English-speaking countries, this leaves a large need for translation in this space. 

Mobile comes into play here once again. To help make healthcare as a whole more accessible (including advice, diagnosis, and monitoring), telehealth services are growing in Brazil. Part of the attempt to make healthcare more accessible is to embrace telehealth, which often takes advantage of mobile applications. 

Translation and localization in the healthcare and pharmaceutical space does not just lead to business opportunities, but also opportunities to create safer and more effective care for Brazilians.

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The Importance of Language Access Surrounding Vaccine Distribution https://terratranslations.com/2021/04/07/the-importance-of-language-access-surrounding-vaccine-distribution/ https://terratranslations.com/2021/04/07/the-importance-of-language-access-surrounding-vaccine-distribution/#respond Wed, 07 Apr 2021 09:59:00 +0000 https://terratranslations.com/web/?p=6387 Vaccines can save lives and the massive importance of vaccine distribution has been magnified by the coronavirus pandemic. When it comes to public health issues, language access is undeniably important (...)

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Vaccines can save lives and the massive importance of vaccine distribution has been magnified by the coronavirus pandemic. When it comes to public health issues, language access is undeniably important. This is especially true for vaccine distribution. In order to make sure proper language access occurs, it’s important to take medical translation seriously. 

Why Language Access Matters

Language barriers can become even harder to break through once you begin to involve complex scientific and medical terms. This lack of understanding can lead to devastating results. During the coronavirus pandemic, researchers found that communities with high populations of non-English speakers had more cases of COVID-19 than English-speaking communities and, as a result, higher amounts of COVID-19-related deaths. Coronavirus incidence rates were as much as 14.3% greater in communities with high populations of non-English speakers. Some experts worry that this is because of language barriers that make it hard to understand the public service announcements that share essential public health guidelines surrounding social distancing, masks, and other strategies for avoiding contracting the virus. 

A Disservice to Vaccine Distribution

In order to properly, and safely, distribute vaccines, the proper distribution of information is necessary. Language barriers can discourage consumers from feeling comfortable getting a vaccine and understanding what the risks are, as well as how to get one if they do want one. 

Language barriers are leading to low vaccination levels for Hispanics in North Carolina. Even though Hispanics make up 10% of North Carolina’s population, only about 2.5% of all coronavirus vaccines administered in the state have gone to Hispanic recipients. Enrolling to receive a vaccine online may be causing problems for non-English speakers who can’t understand the website and the enrollment process. Even though many health departments offer phone assistance in Spanish, a lack of staffing can lead to long wait times and a lack of assistance. A properly translated website could easily increase access to vaccines for the Hispanic community in North Carolina. 

How Human Translation Can Help

When it comes to translating medical information around complex topics like vaccines and their distribution, there seems to be some confusion as to why unsupervised machine translation tools cannot get the job done. As advanced as that technology is becoming, terms and phrases that are more nuanced often end up literally getting lost in translation. For example, recent mistranslation-related events in Virginia caused mass confusion. After utilizing Google to generate a translation of the Virginia Department of Health’s website, their Spanish readers were under the impression that the COVID-19 vaccine was “not necessary.” Why? Because the website showed a translation of “the vaccine is not required” as “la vacuna no es necesaria”, which in Spanish means “the vaccine is not necessary.” 

It’s easy to see how this faulty translation caused misunderstandings that can have a life or death impact. Working with a human translator can help avoid any misunderstandings caused by syntax choices. Translators not only take word choice into account, but cultural and historical influences that can impact how a translated work is perceived.

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The Translation of Instructions for Use (IFU): A Breakdown  https://terratranslations.com/2020/03/09/the-translation-of-instructions-for-use-ifu-a-breakdown/ https://terratranslations.com/2020/03/09/the-translation-of-instructions-for-use-ifu-a-breakdown/#respond Mon, 09 Mar 2020 11:33:43 +0000 https://terratranslations.com/web/?p=1366 Every member of the medical profession should first and foremost prioritize patient safety. One such way to be successful at protecting patient safety is to dedicate resources to the proper translation of “instructions for use” (...)

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Every member of the medical profession should first and foremost prioritize patient safety. One such way to be successful at protecting patient safety is to dedicate resources to the proper translation of “instructions for use” (IFU). Essentially, the term IFU refers to the patient labeling found on many prescription medicines and medical devices. The manufacturer of the drug develops the patient label. But the FDA (a United States government agency) is in charge of approving it. IFUs are especially important when a medication has complicated dosing instructions and the patient may need help using the product properly.

As we live in an increasingly global world, medical device manufacturers and pharmaceutical companies will require assistance translating IFUs into other languages. Quality translation improves patient safety and helps get medical devices and medications approved for distribution throughout various regions. 

Why IFUs Matter

From a consumer standpoint, IFUs are of the utmost importance. The information included in an IFU helps provide the proper use of a medication or device, as well as any necessary precautions. The FDA requires that medication guides, such as IFUs, come with certain medical products. Usually, they do so when they’ve determined that: 

  • The consumer requires specific information to prevent serious adverse effects.
  • A patient has the right to be aware of serious side effects before deciding to use this product.
  • Proper usage of the product is essential to its effectiveness.

Medication guides, including IFUs, must be given to consumers each time the medication is dispensed. It is worth noting that not all medications will provide an IFU. If a consumer ever has questions about a medication, it is best that they consult a healthcare provider or pharmacist. 

Where Translation Helps

Now, looking from a business standpoint, European regulations can provide an example of the importance of translating IFUs. The translation of an IFU is necessary for sale in Europe. Medical products in Europe must have a CE Mark. This mark guarantees that the safety and authenticity of a product are verified and translated properly. 

A CE Mark allows a manufacturer to sell a product throughout the EU. In order to obtain that mark, all materials (such as an IFU) are translated into each of the 24 official languages of the European Union. In Europe in particular, all products must have a CE Mark, which enables manufacturers and traders to commercialize them in the European Economic Area (EEA). 

The Future of IFUs

The standards for medical professionals and products evolve and adapt over time. The digital age is, of course, affecting patient safety regulations. Those who wish to market their products in the European Union should prepare for the emergence of the eIFU (electronic information for use) in 2020. The new eIFU requirements aim to increase medical device safety and effectiveness by providing users with the most current information. An eIFU can include video and audio files, which will make it easier to demonstrate how to operate and handle medical devices. eIFUs will allow companies to bring revisions or changes to the market faster. This extra content will require translation services to ensure all consumers can understand a video or audio file. 

New regulations will be in place in 2020 that medical device manufacturers in the European Union need to prepare for. Manufacturers should be prepping for the change now, including getting ahead on any translation needs.

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Translation of Informed Consent Forms: An Introduction https://terratranslations.com/2020/01/28/translation-of-informed-consent-forms-an-introduction/ https://terratranslations.com/2020/01/28/translation-of-informed-consent-forms-an-introduction/#respond Tue, 28 Jan 2020 11:45:41 +0000 https://terratranslations.com/web/?p=1089 Clinical trials are undoubtedly important. Without them, little scientific or medical progress would be possible. But even more important than the trials themselves, is the welfare of the human participants. They are an (...)

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Clinical trials are undoubtedly important. Without them, little scientific or medical progress would be possible. But even more essential than the trials themselves, is the welfare of the human participants. They are an integral part of the clinical trial process. Their rights and wellness should always be a priority. One way to ensure all participants are fairly treated is through the proper translation of informed consent forms. 

What is an Informed Consent Form?

An informed consent form is a requirement, not an option. A human can not partake in the research process during a clinical trial without signing one. These forms obtain a participant’s consent to participate and inform them of their rights. A participant should expect to find the following information on an informed consent form in a clearly described and understandable way.

  • A summary of the procedure or study.
  • The purpose of it.
  • The duration and schedule.
  • Expected procedures.
  • Potential benefits and risks.
  • Alternatives to participating.
  • The rights and responsibilities of those involved (the participant, study administrators, sponsors, etc.).

The requirements of an informed consent form ensure that a subject’s participation is voluntary. Informing participants about all aspects of the trial is required both ethically and legally. 

Informed consent forms consist of two parts. One part is the information sheet that includes the aspects outlined above. The second part is the certificate of consent. Participants receive a copy of their informed consent form and information sheet. 

Where Does Translation Come In to Play?

Ensuring all research participants are properly informed of what a medical study entails is vital, or else you risk violating a participant’s rights. Being prepared to overcome language barriers can be necessary to ensure no violations occur. A language barrier or poor translation efforts can derail a clinical trial. A barrier can also harm a participant. Particularly if they do not understand what they are agreeing to.   

The proper translation of informed consent forms is a more pressing need than ever before due to the increase in medical research conducted in developing countries. These locales are often chosen as the site of clinical trials because they offer reduced costs. As well as access to affected populations who may benefit from the trial. For some, these trials are the only access to medical care they have. 

What is at Risk?

These trials can lead to new treatments, vaccines, and medications. But they can also violate the ethical rights of the at-risk populations found in developing countries. These violations can occur in first-world countries too. Particularly, in locations like the United States, where different cultures and languages frequently mix. Working with a seasoned translation expert can help avoid these violations and contribute to the success of a clinical trial.

It is not appropriate to exclude a participant due to their inability to read or understand a particular language. Doing so violates the governing principles of human subject research. Respect for persons, beneficence, and justice. Researchers must communicate directly with a subject or provide a trustworthy alternative to ensure they understand their rights, risks, and what their participation will entail. 

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