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.

 

2017 BIO International Convention

There’s no better place to connect with biotech’s top people and most innovative technologies than at BIO 2017. The ideas shared here go beyond professional development. Experience powerful business partnering, benefit from invaluable education sessions and network with 16,000+ of the industry’s brightest.

Meet us at booth 5116.

Life Sciences Round Table at Localization World in Barcelona

Consol Casablanca, Sr. Director Global Client Services, will present “Get Lean! Mitigate Risks and Improve Quality.”  In this presentation, Consol will share real world examples of lean implementation based on client case studies. To manage and eliminate nonquality in clinical trials, Welocalize Life Sciences works to implement lean methodologies. The result: risk mitigation and improved efficiencies and quality. In this session, she will outline the common definitions of waste, show attendees how to identify waste (and language services is just one piece of the puzzle) and share why the cost of getting things wrong is perhaps the biggest area of cost and risk improvement for many organizations.

Meet Consol at LocWorld.

Outsourcing in Clinical Trials Europe

Welocalize Life Sciences are exhibiting at Outsourcing in Clinical Trials Europe (OCT Europe) in Barcelona, Spain, May 16-17. Welocalize Life Sciences can be found at the event on Booth #49.

The OCT Europe brings together executive level delegates working within clinical operations and outsourcing across Europe to discuss contemporary challenges for the industry. With 40+ speakers the program has a mixture of presentations, roundtables, panel discussions, interview sessions and ample networking opportunities.

Contact us to schedule a meeting at OCT Europe 2017. 

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

Clinical Innovation and Partnering World

Welocalize Life Sciences is attending Clinical Innovation and Partnering World on March 8 + 9, 2017 in London. Clinical Innovation and Partnering World is one of the most established and valuable conferences for the pharmaceutical and biotech community. Over recent years, there has been significant discussion about the challenges facing pharma and the resulting need for innovation and change in clinical trials. This event  breaks down the silos of clinical trial development and brings together leading experts in the fields of Clinical Innovation, Outsourcing, Alliance management and Strategic partnering to offer different perspectives on the same challenges.

Contact us to schedule a meeting during Clinical Innovation and Partnering World to learn about our translation and localization services for highly regulated industries.