Developing content and controlling revisions is a particularly critical process in the highly regulated Life Sciences industry. The slightest mistakes can rapidly find their way through a connected chain of internal and market-facing documentation, leaving those responsible with the painful and problematic dilemma of catching all of the errors throughout the documents and online sites all over the world. The problem grows exponentially when this documentation is localized. Revisions to translated content increase time to market and of course the costs. Continue reading »
In many global life sciences organizations, individual markets manage their own translation, either through working from content developed by the corporate office or creating their own. This model supports the local interest; however, as the volume of content and the number of languages grow due to regional expansion, and as cross-discipline life science content integration becomes important, the inefficiencies of decentralization become more obvious.
As we approach a New Year, now may be a good time to consider centralizing your translation efforts. Here are some considerations as you evaluate this model:
Optimized Technologies are Proven and Readily Deployable: In the past, the resources necessary for seamless centralization were not readily available. However, today, the systems needed to facilitate multilingual content development with local input and validations are being successfully deployed by life sciences organizations worldwide. The deployment model involves central control of the process, in tandem with a globally capable language service provider that can seamlessly support an organization’s local operations and protocols, like Lionbridge Life Sciences.
Your Total Translation Costs May be Actually Higher Than You Realize: Translation costs have a multitude of ways of presenting themselves—as pass-through costs from outside agencies at the project level, at the clinical level on research initiatives, and as costs subsumed in local budgets at the regional and branch levels. Adding these costs up could serve as the impetus to realizing there may be a better way.
Achieving Higher Levels of Quality and Efficiency May Be Gained Through Outside Expertise: In each country, standards and protocols vary tremendously, so there may be apprehension surrounding regulatory compliance. As we know, the only constant in today’s evolving global regulatory environment is that local health authorities expect on-time, quality submissions each and every time. Whether you are registering across all EU languages with the European Medicines Agency (EMA), or a select number of languages with local health authorities in China (SFDA), Japan (PMDA), and Korea (KFDA) among others, a broad range of multilingual regulatory submission needs from translation to desktop publishing to XML engineering and independent review are part and parcel to ongoing operations. An outside resource with a proven track record in successful global regulatory submissions may be a benefit to achieving greater efficiencies in the prevailing ‘do more with less’ life science environments, particularly in regulatory functions.
What might the benefits of a centralized model be?
More and more life sciences companies are considering a centralized translation strategy as they bring in a new content management system or an e-learning platform in order to fully transform their global communications model for the digital world.
Centralization makes everything transparent: costs, timelines and quality. Ultimately, though, centralization is not about getting something for less. The real value to life sciences organizations lies in the competitive advantages derived from improving quality, predictability, consistency, strategic use of resources, and the ability of the organization to quickly respond to emerging opportunities and obstacles.
As you plan to further optimize your resources in 2015, how can Lionbridge Life Sciences help you with a centralized translation model to ensure global consistency and local relevance across customers and markets?
Patient recruitment is mandatory for all phases of clinical trials, yet it’s often treated like a distant afterthought. Patient recruitment delays are the main reason why clinical trials fail to complete on time. CW Weekly cited results from research conducted by Cutting Edge Information that an estimated 80% of trials fail to meet enrollment timelines, with as many as 50% of research trial sites enrolling one or no patients. These factors can cause a trial sponsor to lose millions of dollars by having to extend study timelines—subsequently delaying the drug’s regulatory clearance and greatly impacting sales. Continue reading »
Today, the life sciences industry is a key contributor to Singapore’s growing economy: more than 30 of the world’s leading biomedical sciences companies (including GSK, Novartis and Takeda) consider Singapore an ideal location to fuel innovation. In fact, Singapore is on a fast track to becoming the Biopolis of Asia, a leading international biomedical sciences cluster, according to Singapore’s Economic Development Board.
Here are 3 things to know as you consider expanding your life sciences activities in Singapore:
1. Singapore provides a strong scientific foundation – offering seven research institutes and five research consortia spanning clinical sciences, genomics, bioengineering, molecular/cell biology, medical biology, bio-imaging and immunology. Many ongoing programs are underway to address a variety of pressing health-related issues, including:
2. Singapore sponsors several initiatives to attract premier clinician investigators to lead transformative clinical research. The STaR Investigator Award is one such initiative. The award includes a sizable 5-year research grant, an annual salary, and a one time start-up investment of up to $500,000. Investigators are required to commit to a full-time appointment, and the research must be conducted in Singapore.
3. Singapore is home to Lionbridge Life Sciences’ recently expanded Center of Excellence in Asia Pacific, exclusively dedicated to serving the needs of life sciences organizations large and small in this growing region. We support over 250 language combinations that include numerous Asian and Indic languages such as Bahasa Indonesian, Bahasa Malay, Cebuano, Simplifed Chinese, Traditional Chinese for Taiwan, Traditional Chinese for Hong Kong, Korean, Filipino, Hiligaynon, Japanese, the list goes on. Our highly skilled translators are in-country native speakers with life sciences backgrounds. We also have in-depth experience supporting regulatory document submissions to virtually all health authorities in Asia including CFDA, JFDA and MFDS.
If you’re thinking about expanding your life sciences activity in Singapore, and if you consider flawless, timely delivery of multilingual content mission-critical to global success, put our comprehensive life sciences experience to work for you. Read our Asia-Pacific solutions brief here.
In the world of localization, life sciences is different from any other industry because of the unique nature of its requirements. With regulations changing on a continual basis, a premium is placed on quality above all else.
The Life Sciences Business Roundtable offers the ideal forum for senior professionals in all verticals of the life sciences industry – localization included – to meet, share knowledge, discuss trends and impact associated with their line of the business. At the most recent Roundtable in Dublin last month, we presented an agenda of hot topics related to life sciences content and translation management systems, new e-labeling EU requirements, and digital marketing in life sciences. The program was topped by an interesting presentation on the medical technology sector in Ireland by Mr. Donal Balfe, Vice President of Global Manufacturing RMS for Covidien and vice-chairman of the Irish Medical Devices Association (IMDA). IMDA is an association of entrepreneurial sales, marketing and distribution organizations that bring innovative medical technologies to market, whose vision is that Ireland will be a global leader in patient-centric medical technologies. Continue reading »
This year’s DIA Meeting June 16-19th–the 50th anniversary of the Association– was a great success.
The DIA does an excellent job in bringing together leaders from industry, regulatory, and academia, not just to impart their knowledge, but also to develop relationships and gain well-rounded perspectives on the current and future-state of the pharmaceutical industry.
As we heard at DIA, reducing drug development costs and ensuring better outcomes from clinical trials remain universal challenges. These challenges can be translated into opportunities if we work together—within our own organizations and through trade associations like DIA—to identify the high level strategies that support better healthcare for all and together drive the change to allow us to collectively succeed.
As a service provider to the pharmaceutical industry-at-large, Lionbridge Life Sciences supports the industry’s success by offering translation and localization services that maximize global communication effectiveness within the boundaries of a highly regulated, complex and always-challenging life science environment.
And “Global” was clearly the word of the day(s) at DIA 2014. The majority of the 300 presentations at DIA had “international” or “global” front and center in the content. Managing research, regulatory and training teams around the globe are big challenges. Language and cultural differences can serve as impediments to global communication without acknowledging their importance, and carefully planning a localized approach throughout all types of communication.
The Lionbridge Life Sciences booth at DIA had many, many visitors who wanted to learn about new opportunities to support their organizations’ global communications within clinical, regulatory and training environments. We were happy to discuss the ways we have broken down internal and external barriers and have helped our customers implement better ways to globally communicate. In today’s international healthcare economy, there are very few companies that can afford to ignore the needs of local markets. Ignoring localization or approaching it incorrectly can have serious negative consequences—delayed clinical programs, regulatory missteps, decreased customer satisfaction, and lost revenue.
We especially enjoyed the time with our DIA colleagues at the Lionbridge Life Sciences cocktail reception Tuesday afternoon, and hearing what they found most interesting about the event this year. What were your key takeaways from the Meeting? Be sure to be on the lookout for the results of our DIA Pulse Poll in the coming weeks that should shed some light on the key issues facing your DIA colleagues. Feel free to ping me with your e-mail to make sure you receive a copy.
And see you in Washington, D.C. for DIA 2015!
The expectations from Life Sciences customers of their language service providers (LSPs) have grown beyond mere certification to ISO 9001 and ISO 13485 standards. A supplier is seen as a partner in managing quality and risk, and their quality management system is considered an extension of their own. Elements or procedures that may seem secondary from a language service provider’s point of view have crucial relevance to the customer’s own management system, and therefore understandably need to be respected and incorporated. Continue reading »
It’s hard to believe that the DIA Annual Meeting is just weeks away. This year’s theme is built around the 50th anniversary of the Association: Celebrate the Past—Invent the Future. Reviewing the Program Guide, DIA has brought together a balanced representation of the people and technologies that are transforming the future of healthcare. There will be a variety of venues for attendees to learn the latest advances in clinical operations, regulatory affairs, health outcomes and economics, and therapies. And there will be no shortage of insights and observations from industry thought leaders around what helps to shape success in the rapidly changing global health care community. Continue reading »
Expanding into new countries presents unique challenges as you have to train an increasingly multicultural workforce, for those life sciences professionals with a vested interest in developing truly global learning program, you may find yourself asking…
• What should we be doing to make our training more relevant?
• Are we ‘doing it right’?
• What will it cost? Continue reading »
Successful development of a new pharmaceutical product or a new medical device largely depends on the successful recruitment subjects for the clinical trial. Over the past 15 years, pharmaceutical companies have aggressively expanded their reach for clinical trial subjects to developing economies where there is greater access to patients in the disease state as well as a broader representation of the global population for which the pharmaceutical or device is targeted. As reported on clinicaltrials.gov in 2012, as many as 4 out of 10 clinical trials were conducted in the emerging nations within Asia, Latin America, and Africa. Continue reading »