Translation of Clinical Trials Protocols Course: Lessons We’ve Learned 

Recently, two of our hard-working teammates, Silvina and Celeste, took on an intensive training course regarding the translation of clinical trials protocols. The course was taught by Pablo Mugüerza, a very prestigious medical translator, and the course load consisted of about 40 hours worth of material. The material covered topics such as medical terminology and theory. There were also opportunities to practice analyzing different translations. We sat down with our two stellar translators to get their takeaways on the training. They reflected on what they learned and how their new knowledge base will help them moving forward.

What is a Clinical Trial Protocol?

The focus of their training was understanding and enacting correct translation of clinical trials protocols. Celeste explains a clinical trial protocol as an “informative document for the investigators that will conduct the trial. It explains everything that is going to happen, as well as what they should and shouldn’t do.” This document also informs the investigator how the patient will be treated, and what both the benefits and risks are of that medical treatment. She continued to breakdown what a protocol entails, “It explains the design of the trial, how long it will take, where it will be conducted, what medications are being studied, and what is expected of the trial. It also states the purpose of the trial and what they are trying to discover.”

How Was the Training Structured?

For each of the four weeks of the course, the students covered a module that consisted of theory and 25 new terms related to clinical trials. They also tackled translation exercises. According to Silvina, at the end of each module, “There was an exercise, a translation test for us to do. We also had a recap activity to review the terms.” Their weekly assignments were just the beginning. Silvina noted that each week they took tests to confirm they understood and retained the knowledge they learned. There was also a final exam at the end of the training, which they both passed with flying colors. This was an “online test which consisted of fifteen questions about the terms we had learned. And the last week, we also had a final exam. So it was hard work,” Silvina said.

What Were the Objectives of the Course?

The first goal of the course was to gain a deeper view of what a protocol and a clinical trial is. Alongside learning 100 new pieces of terminology and how to properly approach the translation of clinical trials protocols.“My expectations were to learn more terminology, because there is so much information required to specialize in that field. You need to be able to really understand what you have to translate into Spanish,” said Celeste.

What Were the Takeaways?

Both Silvina and Celeste found that this training served as a reminder of the value of education. In a field as critical and challenging as medical translation, it’s key to stay on top of vocabulary, medical advances, and best practices. Silvina greatly appreciates Terra Translation’s commitment to education and training. “I think that training is essential nowadays. In many professions, not only in translation. Because everything is changing and advancing so fast. We must keep abreast of the latest research in this field,” Silvina said.

Celeste also believes adaptability is vital, “You have to be flexible and open minded. You need to know that the education is never going to end. The great thing about being a translator is that you are always learning, it never ends.”

A Reflection on the 2019 ALC Conference: The Pie Keeps Growing

By Colleen Beres

On May 1st, the Association of Language Companies (ALC), kicked off their 2019 annual conference at the Omni Shoreham in the beautiful Woodley Park neighborhood of Washington, D.C. A buzz of excitement and the first hints of spring humidity impressed upon the leaders of language services companies (LSCs) from around the world as they gathered in our nation’s capital for four days filled with camaraderie, education and advocacy. As a first-time attendee of this event, I was surprised by the inclusive and transparent environment of what was, for all intents and purposes, a concentration of my competition. Because of this special environment, by the end of the conference, I held tightly to four major takeaways about the future of the language services industry and how LSCs can maximize short-term and long-term growth.

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1) Expect Exponential Growth of Demand for Language Services

To put it simply, business is booming. Digitalist Magazine estimates that worldwide annual spend for translation services will grow to $45 billion by 2020. As companies continue to cast wider nets into the global economy, they are required to translate content into an increasing number of languages to effectively target new pools of consumers. But even more than a global audience, our world is producing more content than ever before. Combined, these two factors alone can support why demand is growing so quickly. In an overview of trends extrapolated from the ALC annual survey, Konstantin Dranch of industry beacon Nimdzi Insights, shared that two-thirds of LSCs surveyed reported growth in 2018. This is the time for companies push operations hard, expand portfolios with current customers and outline strategies to scale up so that they are prepared to do so when necessary. The pie is growing, and it is big enough for all of us have second helpings.

2) Protect Quality by Cultivating Meaningful Partnerships

Because the horizon is so bright, it will be a challenge for the supply of qualified language professionals to grow at the same pace necessary to meet demand. According to the Bureau of Labor Statistics, the employment of translators and interpreters is projected to grow 18% from 2016 – 2026, which is more than twice the growth expected for the aggregate of all other occupations. LSCs rely heavily on freelance partnerships. When considering the demand projections, LSCs need to not only focus on maturing relationships with company employees, but also with external partners.

Ted Wozniak, President-Elect of the American Translators Association (ATA), shared three major tips that, while seemingly obvious, are necessary reminders of how to effectively develop and protect relationships, specifically with freelance translators. He stressed that we need to cultivate and cherish relationships with language partners in order to leverage their precious supply of talent. How? First, get rid of an “us versus them” mentality. This ideally symbiotic-like relationship can only be fostered if freelance partners are embraced as members of the team, whether it be for one project or continuously – make introductions, pay in a timely fashion, and create opportunities for networking. Second, follow The Golden Rule – do unto others as you would have them do unto you. Simple. And finally, make it personal. The most effective way to engage someone is by using their name. Therefore, tactics that employ the use of “Dear Resource” are not encouraged. Language is not a commodity and those who wield the craft and talent shouldn’t be treated as such. Ted suggests that if a mass email is being distributed, be transparent about it and express that the need is urgent, therefore capacity only allows for mass communication.

Talented language professionals are people first and the greatest assets to guaranteeing our continued success is to treat our people, fully employed or contracted alike, with respect and dignity.

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3) Working Together Makes Our Industry Stronger

I’m relatively new to the language services industry, so my goal in attending this event was to procure a better understanding of macro trends, to create valuable connections that could develop into partnerships down the line and to learn from my much more seasoned industry peers. Before the conference even started, the ALC organized roundtable discussions with topics varying from sales and growth to HR and staffing. There was almost a “What happens at ALC, stays at ALC.” sentiment; very successful CEOs and executives let down their guards and shared their best and worst tales of successes and failures. Does this mean that it was all sunshine and rainbows? Can we anticipate the demise of the free market within the ALC member community? No. Certainly no one was handing off clients to be altruistic, but again the scope of work is so large that offering insight can only bolster a stronger and more structured community. Especially if you are in the small to mid-size LSC, I suggest you proactively seek out opportunities to foster relationships and organized forums. Whether it is the ALC, GALA, Women in Localization… etc. get involved and take a seat at the table. You never know who will be willing to help you once you help them.

4) Embrace Technology to Create Efficiencies… or Die

The conversation of technology in localization cultivates sentiments of both progress and fear in the hearts of many language professionals. While Machine Translation (MT) and Artificial Intelligence (AI) have existed for some time and have created efficiencies never imagined, like automation in many other industries, it has progressively woven in qualms of professional extinction as it all becomes more advanced. The robots still aren’t likely to take over, but I have some thoughts on what will happen. First, the demand for highly specialized talent is going to swell. With the need for linguists to translate repetitive or simplistic text eliminated, the text that they will be called to analyze will be more complex and more subjective. Second, LSCs will need to rely on their commercial teams and “boots on the ground” even more. According to the ALC survey, companies confirmed that in-person connections made the most impact when working to create longstanding and fruitful B2B relationships. Finally, account managers and project managers need to be an extension of the commercial team. Their responsibilities far surpass successful project execution; it is vital for account managers and project managers to foster revenue growth with established clients by promoting additional service offerings and increased volume. Technology is here. LSCs can either adapt and be equally innovative, or they will die. Period.

As I reflect on the four days in D.C., I’m happy to say that I achieved all my goals set out before the ALC conference started. It was a highly educational experience and I made some incredible friends in a very short amount of time. Language is powerful and LSCs are charged with an immense responsibility to create a common voice to cultivate relationships, to drive business and to unify the world. May we continue to work together to embrace and nurture that responsibility.

“The limits of my language means the limits of my world.” ― Ludwig Wittgenstein

Colleen Beres is a Business Development and Strategy Consultant for Terra Translations. She earned her MBA from Northwestern University’s Kellogg School of Management in Finance and Management & Organizations. Colleen has spent the past 15 years of her career utilizing qualitative insight and quantitative data to help safeguard businesses and organizations while promoting successful growth. You can reach Colleen directly at colleen@terratranslations.com.

translation-project-manager

An Insider’s Guide to the Role of a Translation Project Manager

In the world of linguistics, days can be unpredictable and projects layered with varied complexities. A quality Project Manager (PM) calms the chaos with coordination, teamwork, planning, and control techniques. These critical thinkers play an essential role in a project’s overall success. PMs are essentially the gatekeepers to most translation and localization assignments.

A Day in the Life of a Translation Project Manager

There is no daily routine for a PM. Every workday presents a new set of requests, challenges, and hurdles. PMs are the crucial link between the linguistic team and the AM. If translators ever have ambiguity about a project, the PM escalates those questions to the AM. The AM then takes those inquiries to the client to receive further clarification.

It is the responsibility of the PM to smoothly navigate various teams through every phase of a project. This includes the TEP Process, a cornerstone to most of our company’s projects and workflows. Organization and attention to detail are key to ensuring every task is accomplished in a timely manner.

A Translation Project Manager’s Core Skills

PMs are faced with a variety of unique challenges to resolve throughout a project. One of their most valuable skills is the ability to anticipate and manage risk. At times, projects don’t go exactly as planned. An effective PM knows how to analyze the brief, identify areas of the project most vulnerable to errors, and develop a plan to avert risk.

“We do our best to put ourselves in the translators’ shoes and predict any potential mistakes or misunderstandings they may have,” explained Cintia Iorgi, PM for Terra Translations.

Another skill PMs must possess is the ability to effectively communicate. Using various channels, they must confidently convey clear instructions to a team of linguists across multiple time zones. If sending multiple files, PMs must provide comprehensive notes so the wrong content does not get translated. With fairness and goals in mind, PMs need to appropriately address the “needs” of clients and the “challenges” of translators. For example, if a translator needs further explanation about strategy that might affect the translation, the PM must find answers and quickly get him or her up to speed so no time is lost.

Lastly, it’s highly important for PMs to have technical skills specifically as it relates to linguist software. They often utilize Translation Management Software (TMS) and Computer Assisted Translation (CAT) tools to oversee the process. These technologies are constantly integrating and advancing so it’s vital for the PM to keep up with the evolution of the tools. When translators have issues with their CAT tools, the PM must step in to quickly find a resolution as deadlines draw closer.

The Relationship Builders

The core of a PM’s position is the ability to have a genuine connection with people. These relationships develop by the fluid communication and rapport the PM creates with both the client and the linguists.

“The relationships I’ve built is the best part of my role,” said Iorgi. “At Terra, we take pride in the supportive network and welcoming work culture that we’ve cultivated.”

US-Based translation team

Data Protection: Do you Need a US-Based Translation Team?

The internet has opened up a world of possibilities. These days, it’s not uncommon to work with colleagues from every corner of the globe. This global access allows companies to find the best talent, services, and contracts for their business. But there are times where domestic work is an absolute necessity. Some companies and organizations may require working with a US-based translation team in order to prioritize security, protect data, or adhere to strict regulations. Why is that exactly?

Why Work with a US-Based Translation Team?

A company or organization might need to work with a US-based translation team for many reasons. A few scenarios can include:

  • If they need a notarized translation within the US
  • If they have to work with translators who have undergone a background check
  • If any files and information must remain in US territory
  • If specific security measures must be in place

As a safety precaution, some clients that work with sensitive information may need their documents to physically stay within the United States. Meaning, the linguists working on the projects need to be US-based, as do the Project Managers. Even the servers where the files are stored, or are used for transfers, may need to remain in the United States.

Who Needs a US-Based Translation Team

The needs for a US-based translation team can vary, but some of the clients that may require such services include:

  • Government agencies: Local, state, and federal agencies have varying regulations they need to adhere to. The United States government has statutes that all translation services will be performed within the boundaries of the United States. The inability to perform services in the United States can be grounds for disqualifying a contract.
  • The military: As a branch of the United States government, they are also required to meet strict standards regarding translation services.
  • Healthcare providers: Those in the healthcare space, may also need translators and Project Managers to undergo a HIPPA training. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) aims to protect the confidentiality of the protected health information (PHI) that is translated. The US Department of Health has called out their expectations regarding security on their website.
  • Financial institutions: There is a large amount of sensitive data handled by financial institutions regarding business, employees, and customers that is protected by industry and government regulations. If a financial institution works with health care companies, HIPAA guidelines may apply.
  • Companies: Any companies involved in the research, development, sale or maintenance of goods regulated by the US government, such as  pharmaceuticals, may be required to use US-based translation services.
  • Exporters of defense and military related technologies: Under International Traffic in Arms Regulations (ITAR) there are mandatory compliance rules that must be followed regarding translation services for the Defense Department and all of its suppliers.

What We Can Offer

Terra Translations has a robust team of international team members, including US-based translators and Project Managers. As business associates of covered entities, we understand the importance of being HIPAA compliant and our team has undergone HIPAA training with certification.

It is worth noting that HIPAA Rules do not include specific requirements regarding the protection of electronic protected health information (ePHI) processed or stored by a cloud service provider (CSP) or business associates outside of the United States. However, the Office for Civil Rights (OCR) warns that risks related to the ePHI may vary based on location. For example, risks can increase considerably when outsourcing storage or other services for ePHI overseas due to the enforceability of privacy and security protections over the data.

Alongside offering US-based translation services, our project management process meets and exceeds the most demanding requirements, including workflow, timelines, roles, responsibilities, and deliverables.

medical-devices-translation

Why the Translation of Medical Devices is Crucial

Every patient deserves the best care possible. Having a language barrier does not warrant an exception. That’s why it is so vital the translation of medical devices documentation is performed by qualified translation professionals. The process of medical translation deserves the utmost care and professionalism at all times. There are many reasons the proper translation of medical devices is so crucial, the following reasons are a few of them.

Global Reach

With the global over-65 population expected to rise up to 1 billion by 2020, medical devices that improve the quality of life should show steady growth in demand. As will the need for proper medical translation services that ensure user manuals, marketing materials, and medical communications are accessible around the world.

According to OEC, the United States of America is the top exporter of medical devices and mainly exports to the European Union (EU). This means that medical device companies should consider working with qualified translators to make sure their products’ documentation is understandable for the end user. There are 24 official languages spoken in the EU and most countries in the EU require translations into a minimum of one of their official languages. Sometimes more languages are required. Belgium is a prime example. They require French, German, and Dutch translations.

Why Compliance Matters

Compliance is a key element in the localization of medical devices. Manufacturers need to follow the regulations of the countries where they want to market their devices. To market medical devices and their accessories in foreign markets, companies need to remain compliant with international and local regulations in each country.

So how do you balance language requirements if you are exporting medical devices to multiple countries? Generally, there is a strict regulatory approval process for medical devices. You need to review each country’s regulations as they can differ. However, the one overlapping requirement is to provide medical device documentation translation. Any content that goes hand in hand with a medical device must be submitted in the required languages. This content can include:

  • Packaging, labels, mailing materials
  • Usage instructions
  • User interface and software
  • Marketing materials
  • Technical information
  • Patient literature

This is where things get tricky. 22 out of 28 of the EU member states require companies label their medical devices in an official language. Even if the device is intended for only professional usage. That means you may have to translate a device’s supporting documents into all the languages commonly spoken in that region. If you’re looking to distribute your device in the EU, there are six EU member states that accept labeling medical devices in English. However, the device has to be for professional use only. Also, there are some regulatory authorities that might allow limitations to the translation of medical devices requirements. One could be that you only have to translate the device identification label, operating, and safety information. Exceptions like these are why it’s imperative you have a clear understanding of each country’s requirements.

Safety First

Why are the language rules regarding medical devices so stringent? When the lives and well being of patients are at stake, there is no room for error. Simply, being bilingual is not a sufficient skillset to safely handle the translation of medical devices. The patients, doctors, and general public, all deserve high-quality and accurate translations of the content associated with medical devices.