Life Sciences

Global Patient Recruitment: Top Barriers To Efficient Enrollment

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 »

Thinking About Expanding Your Life Sciences Activities in Singapore? Three Things to Know

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:

  • Chronic Disease – improving detection, diagnosis, prevention, and  treatment of many chronic diseases such as diabetes and hypertension;
  • Healthcare Delivery – reducing the cost of healthcare and improving safety, efficiency and outcomes; and
  • Aging –  developing public policies to accommodate the changing age structure and related implications from a healthcare perspective

 

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.

A Booming Medtech Market in Ireland and What an Acquisition Can Do

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 »

DIA 2014: Addressing Challenges to Realize Opportunities… Together

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!

A Quality System that Matters

Stopping at baseline compliance with ISO quality standards is a missed opportunity for both the localization provider and their customers.

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 »

DIA 2014: The Velocity of Change Continues

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 »

Training on a Global Scale: Plan the Work, Then Work the Plan

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 »

Globally Speaking: A Clinical Trial’s Elements of Success

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 »

Outsourcing in Clinical Trials, Brussels… Beer & Networking Anyone?

I am excited to announce that Lionbridge Life Sciences will be proud Sponsors and Exhibitors at the upcoming Outsourcing in Clinical Trials (OCT) Meeting, Brussels on May 21st – 22nd.

During the OCT conference, we’d like to invite you join us on 21/05/14 at 19.30 at Delirium Café, where you can taste more than 2000 beers from around the globe. Delirium Café holds the Guinness World Record for the most beers offered, with close to 2500 available today!

You will be able to choose from the famous Trappists, Belgian Abbeys, strong dark or lighter fruit beers from Belgium, beers from around the world, unusual beers like Chocolate, Banana or Coco beers and more!

Add to that a great decor, thousands of beer memorabilia items such as old advertising plaques, trays, glasses…and get ready to enjoy a great time!

Please let us know if you’d like to join us at Delirium Café by registering here. Continue reading »

Global Training and Development Trends [Industry Report]

We live in a knowledge economy where a skilled workforce and educated audience are key components to enterprise-wide success. A globally dispersed workforce doesn’t just add logistical challenges to training efforts, it also adds a layer of complexity to the technologies promising to reduce the difficulties faced by learning organizations.

So how are organizations evolving their learning strategies and practices to meet growing global development needs? What technologies have been  embrhttp://blog.lionbridge.com/life-sciences/wp-admin/post-new.phpaced by learning leaders and audiences, and what are the greatest challenges to success? Continue reading »