SUPER PMing: THE CONVERGENCE OF LEAN METHODOLOGY AND PROJECT MANAGEMENT

Lean implementation is a transformational process. Through lean and effective project management services, Welocalize Life Sciences has been able to eliminate waste from our translation and localization processes, thus creating robust and efficient workflows. These improved workflows enable us to provide greater quality across the entire process with faster turnaround times.

In this Q&A with Nandia Savvopoulou, a production director at Welocalize Life Sciences, we discuss how we are continuously improving our processes and creating new efficiencies that are adapted to meet our clients’ needs.

Welocalize Life Sciences: How does lean methodology impact the project management process?

Nandia Savvopoulou: It impacts the way a project manager is thinking. Once the way of thinking changes, so does the acting; the focus switches. People normally tend to use arguments like “human error” instead of thinking that the process in place might leave too much room for human error. When something goes wrong, or results are not the expected outcome, we leave the blame thinking perspective behind and instead focus on the process. Implementing lean in the services industry is challenging, but not impossible.

WLS: How do you define efficiency?

NS: Efficiency is the maximum use of resources while minimizing waste, while being innovative and automating processes. When a client has concerns about quality, a typical reaction might be to provide, as preventive action, a second round of revisions or QA. That is a fitting example of lack of efficiency.

WLS: How do efficiency and project management intersect?

NS: We believe that through a detailed project initiation and a smart linguistic selection we get the highest chances that a project will run smoothly. We spend hours or days, if needed, in preparing instructions, preparing files, creating macros, investigating machine translation best options, and convincing a certain linguist to accept the project. Our objective is to do things right in the first step. Nothing can go terribly wrong in the end if the project was properly started. 

WLS:  Can you give an example of a time consuming and repetitive project where lean methodologies and project management efficiencies helped smooth out the process?

NS: Although there is a continued push in the industry for automatization, there will always be projects that demand manual work. A good example is the translation of case report forms. With hundreds, or even thousands, of scanned pages filled with handwritten text, most of time very little is legible, you cannot automate these projects but you can take steps towards efficiency.

We recently had a tight deadline for the translation of more than 1,000 pages from German to English (DE-EN). We had an estimation of 150k words for translation and five weeks to complete it. In the past, we would send the file for formatting and we would then translate and review. Once ready, we would clean up the files and send them to the translator to fill in the translation of the handwritten text. This is a long and expensive process, and one that obviously involves manual, human translation and work.

WLS: How did WLS team resolve these challenges? Was it a successful project?

NS: First, we did not panic. We had faith that we would get the results we were hoping for and we did!

This time, instead of sending out the package for formatting we studied the files. During this process, we discovered patterns of repeated templates and text. So, we dedicated a week to creating a tracker, a report where the details of source files were registered. Then, we extracted the templates that were appearing only once and this way we spent minimum time formatting. Once we had the formatted files, we “built” the source files based on the info we had gathered. For example: File 1, use template X pages 3 and 4 for sources pages 7 and 8.

Another differentiation from the past was how we dealt with handwritten text. When translating from DE-EN, you have an EN native working on the project. However, natives of the target language do not always have great skills in deciphering handwritten text of the source language. We implemented a new step that involved a German native deciphering and typing all handwritten text.

Out of 170k words, there were only 15k new words. When the translation and review was over, the clean files came out impeccable. The QA took one-third of the time it usually takes, as we had implemented many QA steps and safety nets before starting translation. Costs were kept to the minimum possible. In addition, we had interns helping with the tracking and the QAs.

WLS: What is a typical mistake a project management team makes and how can this be avoided?

NS: One of the greatest—and most typical—mistakes committed is to start translating as soon as the project arrives. For example, rush deadlines “steal” focus and disorient the PM. The sole challenge seems to be the limited time. Even though the clock might be ticking, we need to stop – for a day, a week – and think. Think how we can do things better.

WLS: Any additional input or advice?

NS: I think you add value to a project by getting support groups involved (Vendor Management, Language Engineering, Developers and DTPers/Formatters) in the first steps. Project managers tend to only turn to these people when something goes wrong. Welocalize Life Sciences believes in having these team members add value to the first step, during pre-production, for a more holistic and effective project management roll-out and process. Lean says: Use talent. I believe there is great talent all across our company and the smart thing to do is use it.

Language Tips for Medical Tourists

Medical tourism is booming. According to Transparency Market Research’s report, “Medical Tourism Market,“ factors like aging population, escalating healthcare costs, and better exchange rates push the case for this rise in global medical tourism.

Besides escalating healthcare costs, many medical and surgical procedures are no longer covered by insurance providers. This has caused many Americans to cross borders in search of alternative, affordable options for their healthcare treatments.

But is it realistic (or safe) for travelers to only communicate in their native language when traveling to for medical care?

Medical jargon can be confusing in any language. Medical tourists can take several steps to ensure that they are linguistically prepared for their trip and avoid being lost without medical translation.

Translate your medical history before you travel. Detail any major illnesses, medication, allergies, etc. and avoid abbreviations. If you do have a medical emergency and no one can speak English, you can at least produce this document with your vital healthcare information. Find a professional translation agency to do it for you. Don’t rely on free websites or translation software.

Ask for information to b provided in your native language. If not, does the medical facility have access to on-site interpreters? Or, do they have other English-speaking staff?

Use a telephone interpreting service. There are several companies that provide immediate access to interpreters via telephone. You can also bring along a prepaid interpreter card. These cards provide pay-as-you-go interpretation between English and a number of other languages.

Know your emergency contacts. Ask the consulate, your medical travel agent, or hotel concierge if there is an emergency resource available, similar to a “9-1-1” service in the U.S. Note that in some countries, there are different emergency contact numbers for police versus ambulatory care. Tip: Here is a country-by-country list of emergency telephone numbers.

Bring resources with you. Carry a foreign language translation dictionary or a pocket translator with you at all times in case you do run into difficulties and need a little help making yourself understood. Most smart phones also have downloadable apps, however, keep in mind the cost of international data and roaming charges.

Ask for tools. Some facilities will have cards with common images on them where you can point to your illness, need, or food choice. You can also bring your own along. This is an especially good idea for people with severe allergies.

Learn basic phrases. It’s always a good idea to learn a few words and phrases before your trip. For example, “I do not speak Vietnamese. Do you speak English?” is a good start in addition to basic local greetings.

If your life depended on it, would you rely on using untranslated medical documents for your medical care or procedure?

Contact us if you’re in need of medical translation services.

Going Global with your Social Media Strategy

Thanks to Facebook, Twitter, Instagram and other social and rich media outlets, your customers and patients have a forum for voicing their opinions about your services. The rapidly evolving social networking landscape provides an open playing field for consumers to access your materials across global, cultural and linguistic lines. Social media is also increasingly becoming a useful and valuable tool for clinical trial recruitment through engaging with online patient populations.

The good news is that social media provides direct access to a global network that extends far beyond the reach of your personal email list. The bad news is that this network is made up of people who speak a lot of different languages and have a myriad of preferences and expectations.

Successful social marketers know that the success of their messages hinge on speaking to their buyers directly, and regional language and cultural preferences can greatly impact this success.

Social Media’s Global Landscape

The reality for global marketers is that the rest of the world is just as engaged—if not more so—in social media channels. According to a recent study conducted by The Nielsen Company, the reach and usage of social networking and blog sites in Brazil, Italy, Spain and Japan has surpassed the United States and United Kingdom. Further, Twitter’s blog states that at present, over 60% of Twitter accounts are registered outside of the United States. Thus, even for brands that originate here in the United States, the conversation had around that particular brand or product instantly becomes global when a social media presence has been formed.

Getting Strategic with Global Social Media

The ever-changing landscape of social media has made it no small feat to satisfy the needs of a diverse market. Yet, rather than cower at the vast sea of voices coming through the social media channels, some marketers have learned how to effectively harness these networks to truly listen to their customers voice and develop creative ways to speak to the masses as individuals.

According to Sasha Strauss, managing director and chief strategist at Innovation Protocol, a Los Angeles based brand strategy company, the age old tendency to aggregate consumer groups by demographic is not only unfair, but these categories are subdividing faster than we can keep up. Many of the old tactics employed by marketers in the past just do not work anymore under the current paradigm.

For instance, the notion that you can just swap out images in a campaign to make it appropriate for different countries around the globe no longer applies carte blanche. Plus, simply translating marketing messages without a clear indication of who you are taking to and what their expectations are does not work either. The present truth is that you are dealing with different demographics for each audience and they will expect different things as buyers.

Despite the similarities that tend to group people into a specific demographic, the fact that consumers have consistent access to all information put out through social media allows them to move back and forth between categories more easily. You can’t just assume that all women over 40 in Spain think and operate the same way that women over 40 do in the U.S.

According to Strauss, here are five things to consider when creating your global social media strategy:

  1. If you have a social media presence you have already sent an invitation to hold a global conversation.
  2. You cannot afford to get complacent. The difference between the old paradigm and the new is that information is moving fast, without keeping your finger on the daily pulse much can be missed by way of information that can help guide your efforts.
  3. Ask yourself, what is culturally relevant now? And do the research to back it up.
  4. Listen to your network! Companies and agencies have an obligation to ask their customers for guidance and when they respond, take the time to really listen.
  5. Social media not only makes your local networks global, but it also brings the global network to you. You can effectively use these channels to mitigate cultural or linguistic faux pas by tapping into them by way of a casual reality check. (Innovation Protocol often uses their social media networks to conduct small virtual focus groups – held in a secure environment – across countries, cultures, race, gender, etc. in order to get feedback and sense-check their brand strategy).

Tackling the Language Barrier

Language is just one of the many challenges faced when addressing a global network through a dynamic outlet like Facebook. When surfing the social media pages for various brands and products (maybe even your own) it is not uncommon to see commentary from people based all over the world. In capturing this feedback, language can sometimes serve as a barrier if your organization does not have in-house resources to read and effectively interpret these comments in other languages.

There are various online applications that will assist you in translating content for free using machine translation, e.g. Google Translate. While these are fine for simply getting the gist of what others are saying for internal purposes, please note that we have found on average that most applications are only 60% accurate and thus, should never be used to construct your marketing messages, lest you be left sounding like a babbling fool. Caution should be exercised even when casually responding to feedback. The best approach is to rely on an experienced agency or language services partner that can assist you in translating feedback and guide you in transcreating messages that would be appropriate for your specific target markets.

In short, there is no need to get washed up by a social media swell. With some careful forethought, active listening, and experienced partners to assist you, capturing the global voice through these channels is very doable, if not a must, in order to keep up.

Contact us for a free, no obligation quote of your marketing and advertising translation projects.

Selecting a Language Services Provider

Entering a new market can be challenging—from unfamiliar cultures and languages to different laws and regulations to localization considerations. How can you be sure you are selecting a translation team that has the experience and the training to accurately convey your message in the target language and culture?

Welocalize Life Sciences offers the following tips for selecting the right language services provider to ensure a successful translation process:

Price is only one factor. Quality, skilled translators cost more. However, selecting the higher priced language services provider does not guarantee the best translation or accuracy. Other factors to consider include experience, quality, technology and more. And, while the lowest price doesn’t necessarily mean you’ll receive a poor-quality translation, rock bottom pricing could mean providers are cutting corners. For example, they may choose not to follow a multi-step quality process. Instead, they use one translator and skip the editing and proofreading stages by other team members. Find out more about the true cost of translation.

Commitment to quality. Make sure that a defined workflow and documented quality assurance procedures are in place and are used at all times.  Look for a provider with a firmly established project management process involving different team members (translation, editing, proofreading). Don’t be afraid to ask the provider how they ensure quality. For example, Welocalize Life Sciences implements lean methodologies to create an efficient system of continuous improvement.

Staffing decisions. Just who is really doing your translations? Are you working with a one-person show, or does the provider have a large pool of translators to pull from? Were all those translators carefully screened and tested during candidate selection process? Does the agency require its translators to be degreed? Does it have an in-house certification program? Translator selection criteria should include native fluency in the target language, a linguistic degree from one of the world’s major universities or language schools, industry specialization demonstrated by an advanced degree or specialty translation experience and more.

Industry expertise. Not everyone who speaks a foreign language is a translator. Ensure your provider has experience in your industry, understands the regulations and nuances of your business or service, demonstrates an efficient quality process and can supply a reputable client list with references.

Local market knowledge. To resonate with a local market, sometimes translation needs to be taken a step further, which is where transcreation fits in. Transcreation is about taking a concept in one language and completely recreating it in another language – it is normally applied to the marketing of an idea, product or service to international audiences. The experienced translation agency will address region-specific cultures and dialects. Brand names may need to be adjusted to avoid different connotations in the target language that might not make sense or even be damaging or offensive. For example, Coca-Cola sells a lot of Diet Coke in the U.S. However, the company renamed it Coca-Cola Light to market and sell it in many countries where the word ‘light’ means fewer calories.

Use translation memory (TM) tools. Translation memory (TM) software analyzes repetitive text in the source documents and then queries a translation memory database to identify previously translated segments. TM ensures consistency of terminology, expedites future revisions, and reduces translation costs. Consistency is improved because the TM software will always propose the same translation for the same source sentence. Even a large group of translators, working from different locations, can produce consistent translations, provided they work from the same translation memory. TM, together with other tools such as computer-aided translation (CAT) tools and machine translation (MT), provide distinct advantages that create powerful tools to streamline translation and localization processes. Find out how Welocalize Life Sciences uses technology to speed up the translation process.

Centralize the translation process. Successful translation is also an internal initiative. Often time, global companies with several offices around the world rely on their distributors, agents and representatives in other countries to do the translations.  By “centralizing” translation management via one department, a core contact team, or even a designated project manager, companies can streamline all translation efforts and communicate their messages across to various countries more consistently, effectively and, often, less expensively.

If your materials, products or trials are crossing borders, contact Welocalize Life Sciences for more information about our professional translation and transcreation services for highly regulated industries.

 

Mitigate Risks and Improve Quality with Lean Methodologies

Lean implementation is a transformational process and should support organizational development alongside process improvement. Non-quality in clinical trials (e.g. late site activation or inaccurate data) can be costly and disruptive.

In this Q&A with Welocalize Life Sciences Senior Director of Global Client Services Consol Casablanca, we discuss why the cost of getting things wrong is perhaps the biggest area of cost and risk improvement for many organizations.

Welocalize Life Sciences: What is the lean concept?

Consol Casablanca: Waste is anything that does not add value; it only adds time and cost. Lean methodology consists of eliminating waste from processes so that they are efficient and effective. It’s based on two concepts: Doing it right the first time and Just-in-Time (JIT). Doing it right the first time means if there is a problem, work stops until the problem is resolved. The principle that underpins JIT is that production should be ‘pulled through’ rather than ‘pushed through’. This means that production is specific to customer orders, so that the production cycle starts once a customer has started a project—no more, no less; no sooner, no later.

WLS: Why should companies implement lean methodologies?

CC: Lean methodologies allow companies to: accelerate the transformation process; become more client-oriented; develop employees through empowerment; and create an efficient system of continuous improvement. The implementation of lean methodologies is a key factor for providing better service to our life sciences clients. Through lean, we have been able to eliminate waste from our processes, thus creating robust and efficient workflows. These improved workflows enable us to provide greater quality across the entire process with faster turnaround times. We are continuously improving our processes and creating new workflows that are adapted to our clients’ needs.

WLS: What are some challenges sponsors or CROs face when conducting clinical trials?

CC: There are several challenges sponsors and CROs face during the global clinical trial process. Here are just a few:

  • There is an increasing demand for clinical trials being carried out in Asian countries, however there are limited resources for some regional/local languages.
  • Ethics committees/Institutional Review Boards not accepting translations of Patient Information Sheets/Institutional Review Boards because of low legibility, causing a delay in the start of the clinical trial in that country or site.
  • Different documents need to be translated or can be kept in English depending on the target country.
  • Patient-reported outcomes need to be perfectly understood in the same way by patients in different countries in order to be able to pool the data across countries.

WLS:  How can Welocalize Life Sciences help with these challenges?

CC: With offices all over the world, Welocalize Life Sciences has easy and quick access to almost all possible target groups. Through standardized but flexible translation workflows we can guarantee quality translations even into languages where finding qualified resources seems impossible.

Thorough pre-production, expanded clinical investigation term data bases, translation memories of thousands of approved translated segments, support to translators throughout the life cycle of the projects and innovation in technology are only a few of the steps we take to guarantee high legibility in our translations.

To manage and eliminate non-quality in clinical trials, Welocalize Life Sciences implements lean methodologies. The result: Risk mitigation and improved efficiencies and quality.

WLS: Any additional input or advice?

CC: In addition to eliminating waste from our processes and creating efficient workflows, Welocalize Life Sciences works with qualified, experienced medical translators to doctors and healthcare professionals that provide advice and support in all regulatory and legal matters. Moreover, our production team is highly experienced and up to date with all new regulations and industry trends. Implementing lean methodologies, working with subject matter experts and client-focused processes are all key factors for providing better service to our life sciences clients.

Learn More

Consol will present at the Life Sciences Business Round Table at LocWorld Barcelona, June 14, 2017. Attendees will benefit from this session in multiple ways. She will show how to identify non-quality costs in order to reduce them by implementing corrective measures. Find out more or register at LocWorld.com.

 

Machine Translation Addresses the Need for Speed in Clinical Studies

Increasing the speed and efficiency of clinical studies is a well understood and agreed upon priority of most clinical operations professionals. However, according to CenterWatch 86% of clinical trials experience delays and 81% of these reach one to six months in length, with 5% of delays lasting even longer.  One approach to speed up the translation portion of the clinical process is the use of machine translation (MT).

MT is a technology that automatically produces translations of text without human intervention. MT output is frequently part of a larger translation workflow that involves humans as post-editors or reviewers. It requires previous production and consistent data collection to create a knowledge domain that will produce accurate outputs. In order to work with MT in a smart and professional way, it is crucial to work together with other market tools such as computer-aided translation (CAT) tools. This technology provides distinct advantages that create powerful tools to streamline translation and localization processes, including:

Cost reduction. Because modern MT systems can translate high volumes at low cost, they enable sponsors and companies to translate more text into more languages. For life sciences companies dealing with millions of source words, MT is a viable piece of the translation puzzle.

Faster time-to-market. MT systems can translate text at speeds that human translators cannot match. This enables them to meet on-demand requirements or to meet turn-around times that traditional processes cannot match.

Accuracy. MT systems allow for improved quality, in terms of accuracy, orthography and consistency. It avoids errors, especially omissions, that can sometimes occur with human translations.

Tool integration. MT systems are increasingly integrated with other translation tools, such as terminology and translation memory. The merging of these technologies has a direct benefit in terms of the quality of raw MT output, but also supports human-centered production methods that combine the speed and volume capabilities of MT with the quality and intelligence of human-translation processes.

Life sciences companies looking to decrease time-to-market and translation costs, without reducing quality, have a variety options. MT solutions can include various degrees of software training inputs combined with light or heavy post-editing to refine final proofs. The important thing is to find a language services provider with access to a range of solutions, including MT, and then works to best suit the needs of their client.

After more than a decade of training a specific MT engine tailored for clinical trial documentation, Welocalize Life Sciences is seeing incredible results. In an average 10,000 word document the average human intervention is only between 1,500 to 3,000 words. That means that 70% to 85% of the words are translated correctly by the translation engine, and the post-editor only concentrates on 15% to 30% of a document. The integration of MT solutions can lead to greater cost savings and faster market entry, making valuable therapies available to patients sooner.

Contact Welocalize Life Sciences for more information about our experience in translating multilingual documents for clinical studies around the globe.

 

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 healthcare 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.

Clinical Trials: Patient Recruitment, Education and Retention

World Globe with Stethoscope

Clinical research is expensive. When a study does not reach minimum participation thresholds, pharmaceutical companies stand to lose millions of dollars, not to mention the lost opportunity of improved healthcare. Through clinical research, we gain insights and answers about the safety and effectiveness of drugs and other therapies. Advances in drug development are possible because of the participation of clinical research volunteers, both healthy and ill. Clinical trials constantly need a steady flow of patients and it is an ongoing challenge for CROs, sponsors and medical centers to gather the right patient groups.

The Wall Street Journal reports that nearly 40% of all clinical trials never get off the ground due to lack of participation. For decades, clinical research recruitment has largely been a word of mouth and paper-based process. Patients typically find out about available trials from their doctors, who might have limited information to provide about the specifics of the trial. Additionally, for patient recruitment, clinical trial studies are promoted through a variety of different channels such as television, radio, newspapers and the internet. Another way drug companies are reaching new markets is through expanding clinical trials into new markets.

According to an IDC research brief, mobile and other technologies may be the future of clinical research, in terms of increased participation and patient retention. By using technological tools, researchers can more effectively recruit trial subjects and gather more accurate clinical trial research. According to an IDC research brief “The Internet of Things and Digital Transformation: A Tale of Four Industries,” some ways that technology is being used to improve clinical trials include: Developing centralized databases that patients can search for potential opportunities; electronic health record (EHR) matching; improved patient education; and electronic data collection.

Lack of Participation
In addition to lack of awareness, there are many different reasons why people do not participate in clinical trial studies. Here are a few:

  • Lack of knowledge: People do not know that clinical trials can lead to a solution to their health problems or even know what clinical trials are.
  • Do not meet the study requirements: Some people are interested and willing to participate, but come to find they are unable to enroll or complete a trial for a variety of reasons.
  • Fear: Many people are reluctant to participate because they are afraid. Unknown outcomes, uncertainty if a new treatment can help them, being experimented on, possible side effects and receiving a placebo instead of an actual treatment are a few common fears. Although researchers cannot guarantee outcomes, patient safety is a top priority. Each trial has enforced oversight, and patients also have rights that help protect them.

Patient Recruitment + Education
Many patients and health consumers know very little, if anything, about clinical trials and its process. Educating patients and potential study volunteers is key to successful patient recruitment and retention. CenterWatch offers IRB-approved brochures specifically created for patients for use by sponsors, CROs and medical centers seeking to educate potential patients about clinical trials, as well as help patients make an informed decision about clinical trial participation.

The results obtained from a clinical trial study may generate changes in diagnosing, preventing, treating or curing diseases or disabilities. The participation of volunteers is crucial, medical advances depend on their participation to get the knowledge and answers regarding the safety and effectivity of the drugs and treatments to be analyzed. Without patients, clinical research doesn’t happen.

Welocalize Life Sciences specializes in the translation of clinical materials, including patient education and patient retention documents, helping CROs and sponsors reach diverse patients in more markets. Contact us for more information about professional medical translation services.

Holidays, Colors, Traditions and Suspicions Across Countries and Cultures

Ball Lights

To establish a global brand, it really does pay to invest in localization, right at the planning stage. Localization goes beyond just language. It makes certain your content resonates with your global audience on a personal and cultural level. Research on consumer habits, values and customs in the markets you are expanding into can help ensure your brand campaigns are prepared and developed with the target audiences in mind.

Consider these suspicions, traditions, holidays and the meanings of colors across countries:

China: Around the world, the way different cultures see and describe the meanings of colors varies dramatically. Colors may convey joy or prosperity in one culture, and doom or bad luck in another. In China, the color white is a color of mourning, while black is the color or mourning in many other countries. Red is a very important color in China — it symbolizes good luck, joy, prosperity, celebration, happiness and a long life. Because it’s such an auspicious color, brides often wear red on their wedding day, and red envelopes containing money are given out during holidays and special occasions.

Russia: Stay clear of the big 4-0 birthday for men. A common superstition in Russia is that when a man is 40 and celebrates it with a big party, it may attract the Death. If this birthday isn’t celebrated, there is less a chance that Death remembers there is a man somewhere to be soon taken.

Japan: One of the most important aspects in Japanese language is that there are different tones or voices depending on the speaker, the listener, level of formality and situation. Therefore, messages are written specific to the sender and the receiver. For example, in Japanese, it is a bit awkward to use expressions that are too casual or romantic with parents – you do not send “kisses” and “hugs” to your mother or father.

Greece: Sorry, Easter Bunny. In Greece, the Easter Bunny tradition does not exist. Bunnies can be used on cards but “Easter Bunny” itself is not considered a symbol of the holiday, e.g. the way Santa Claus represents Christmas in the U.S.

Spain: While finding a four-leaf clover and touching wood are considered good luck, Spaniards believe that Tuesday the 13th is a very unlucky day. If you live in Spain, or many other Spanish-speaking countries, it is the equivalent to Friday the 13th in the U.S. “Martes,” which is Tuesday in Spanish, is a word derived from the name of Mars, the God of war. Therefore, the belief is that Tuesday is ruled by Mars, the god of destruction, blood and violence.

Ireland + the UK: “Happy Mother’s Day!” Yes, we all want to share our well wishes with our moms, but these sentiments are shared on the fourth Sunday of Lent, typically in March in Ireland and the UK. Here is how (and when) many other countries celebrate Mother’s Day, as per Time magazine.

As companies become more global, it is beneficial to understand the potentially diverse cultural the meaning of colors, images, traditions and holidays. Find out more about transcreation services from the experts at Adapt Worldwide, a Welocalize company.

Contact Welocalize Life Sciences for more information about why localization and transcreation are important components of the marketing and commercialization process for pharmaceutical, medical devices and healthcare companies.

Conducting Clinical Trials in Latin America

Globe puzzle and stethoscope

In today’s competitive landscape speed is key in getting a drug from discovery through to market. Everything that speeds up the clinical trials process (without sacrificing safety and quality) is a priority to today’s drug developers because it is essential in shortening a product’s time to market. Clinical trials across multiple regions of the world have become common practice, with the goal of bringing new drugs and devices to patients around the world, as fast as scientifically possible.

Conducting clinical trials in Latin America provides sponsors large patient populations within a condensed geographical area. For example, more than 626 million people live in Latin America, with 70% of the population concentrated in urban areas like Buenos Aires, Mexico City, Sao Paulo and Rio de Janeiro.  Additionally, the commercial markets are attractive due to relatively lower cost for greater speed.

Latin America offers patients in medical centers with competent and qualified investigators and established regulatory systems at comparable cost. There are challenges, however, that require forward thinking and strategic planning to optimize timely study start and execution.

Selecting an Outsourcing Partner

One of the most important decisions a sponsor makes is choosing the right outsourcing partner to execute a successful clinical trial program in Latin America. Clinical trials conducted by a Contract Research Organization (CRO) may be completed more quickly than those conducted in-house by pharmaceutical companies, and there are some very compelling reasons for that.

A CRO with representation within the country will possess the expertise to navigate the waters of regulatory submission requirements within each given country, and lack of regulatory harmonization makes it challenging for the novice.  Approval times vary widely and omission of required documents will delay review.

Furthermore, challenges to be expected and managed include status of Intellectual Property protection from country to country, cultural and medical differences, logistical challenges around drug storage depots, patient biologic sample handling, regulatory challenges associate with adaptive trail design, ethic review process and more.  Site feasibility alone must consider public perception and work to dispel misconceptions in multinational trials and identify and train sites of excellence, both in the private sector and in large metropolitan facilities.

An outsourcing partner must understand issues that affect the conduct of clinical trials unique to each country within Latin America, and be versed at accessing patients. They must have a representative that is a source of local culture, to provide insight to accommodate the diversity that exists within a given region in a country, and to address the challenges and concerns that arise.

Translation and Language Barriers

In addition to outsourcing the study execution, there is a translation component—working with a language services company who not only specializes in local languages and regional variations, but also translation of clinical research and regulatory documents. Only in some countries, the investigator´s brochure and a few other documents can be submitted in English, but these are rare exceptions. It is important to note that even though Spanish is spoken in most countries, except for Brazil, the meaning of certain words and phrases varies between countries.

Addressing language barriers therefore requires an understanding of the patient demographics in each country. Although all regulatory documents must be provided the official and written language of the country, any patient-related materials must be adapted for the target patient population. For example, the people of Peru predominantly speak three different languages: Spanish, Quechua and Aymara. In Colombia there are about 65 indigenous languages and nearly 300 dialects. Colombian Spanish is a mixture of the Caribbean dialect and Peruvian coastal dialect.

Dominant indigenous populations not only influence the way the language is spoken in each of these countries, but they are also responsible for differences in the local culture. Among the most common reasons for delays by ethics committees are problems with informed consent, and these are often associated with poor quality translation. In large part, this can be avoided if linguistic and cultural differences are properly addressed. Experts who are native speakers and have a background in clinical research are best equipped to perform such culturally sensitive translations.

Find Out More

In our next issue of Global Communicator, we expand on the topic of overcoming outsourcing challenges and working with qualified partners in all stages of the process. Sign up to subscribe to our monthly newsletter for more articles and resources specific to global life sciences companies.

For information on how Welocalize Life Sciences can accurately and efficiently translate and localize clinical research trial documents for Latin American countries, contact us.

For more information on conducting clinical trials in Latin America, consider these research-based papers and reports:

Cancer Clinical Research in Latin America

Doing Clinical Research in South America

Latin American Contract Research Organization Market