The Drug Information Association (DIA) is an association long-recognized as playing a significant role in transferring vital information across the globe to help raise the level of health and well-being worldwide. Many DIA members are innovators in science and medicine, driving forces behind global research and the medicines that result. Lionbridge Life Sciences had an opportunity to hear from dozens of DIA members at their annual meeting in June in Washington D.C. regarding key factors surrounding global clinical trials. Continue reading »
The expectations from Life Sciences customers of their language service providers (LSPs) go beyond mere certification to ISO 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.
Commitment and Discipline Essential
Maintaining an effective Quality Management System is not a trivial job as it requires commitment from management, dedication of qualified resources and, as importantly, operational discipline. Efficiency is key to feasibility through the proper use of existing tools, materials and practices to achieve full compliance. Therefore, these additional expectations from customers may at first seem an extra hurdle, but in reality can offer both the customer and the LSP many incremental benefits:
A Stronger Partnership Results
However, the ultimate benefit is when the localization provider’s quality management system evolves to more closely resemble that of its customer, it builds up an understanding of the customer’s business environment and gives both customer and supplier a common platform to collaborate towards improved product quality and an even stronger partnership.
A strategic quality system does not reflect a theoretical standard, but becomes itself the standard between supplier and customer, which they can in turn use to align common goals and avoid shared risks.
What strategies have you devised to make sure your evolving Quality Standards still align with your Language Service Provider’s? Please let me know your thoughts by contacting me at email@example.com
Marcio Correa is Manager, Global Quality and Process for Lionbridge Life Sciences, serving as ISO Management Representative and Certified Lead Auditor, and holds a Lean Six Sigma Black Belt.
When life science companies launch clinical trials in markets around the world, translation is a key requirement, but more commonly than not is one of the last issues to consider in planning a global clinical trial. Translation is inarguably on the critical path to helping achieving clean data and ultimately the trial’s success.
Adverse events can derail a clinical trial—or sales of approved products—when not properly managed. In-market regulatory bodies require timely reporting of all adverse (AEs) and severe adverse events (SAEs), and with that, life science companies need an established translation strategy to communicate those negative episodes in a timely manner and in the correct languages.
The Dynamic Duo of AE Goals: Speed and Accuracy
Life science companies typically choose one of two methods for adverse event translation: internally through the organization’s Safety department, or outsourcing. Companies that translate the reports themselves often experience long delays because they don’t have translators dedicated to the effort; and the employees who do the translating have other job responsibilities. A long translation process postpones the reporting and the release of the adverse event to the regulatory body (typically required within 24 hours for SAEs and 48 hours for AEs).
Companies choosing to outsource to a third-party are usually hoping to avoid burdening their team with translation work, but still need to translate and report the event as quickly and accurately as possible. Unfortunately, not all third party providers are equipped to support the time-sensitive, quality-driven requirements of adverse event translation.
How Can a Partner with Dedicated Resources and Unsurpassed Expertise Help?
Lionbridge Life Sciences has an established track record of reducing translation turnaround times for clients, often by more than 30%. We have a dedicated Adverse Events team and fully-operationalized program in place to deliver priority services ideally-matched to the unique requirements of time-sensitive, multilingual AE and SAE reporting.
Our Adverse Events Program offers:
We specialize in all aspects of clinical trial translation, from pre-clinical and clinical to post-approval pharmacovigilance, providing Certificates of Accuracy for the utmost assurance. Wherever you are in the process, we have a solution to help your trial succeed globally.
Reporting adverse events quickly and expertly is undoubtedly challenging, given the differing international regulatory standards, but all the more reason to have a proven partner and process in place as your clinical activity and sales expand globally.
To learn more about how we can readily deploy an adverse and severe adverse event translation program to meet your needs, contact Lionbridge Life Sciences today.
Author: Hocine Ladraa, Process Development Manager, Lionbridge Life Sciences
As we all know in a service business, a longstanding relationship is often the greatest measure of the value being derived by each organization. Lionbridge has been proudly serving as the translation partner to a global medical device manufacturer for more than a decade. This longstanding relationship has offered Lionbridge the opportunity to bring forward new strategies built upon a record of success over the years. The premise to one such strategy was in our ability to leverage the accumulated market knowledge and centralized technical content as a basis for creating a brand new type of content— and to respond even faster and better to new translation needs.
Here’s a closer look:
Ongoing translation and localization services for technical manuals and other associated content pieces supporting the use of our client’s medical devices have been mainstay services over the years, which has led to the establishment of a dedicated team of experts in the field. When our client asked us to initiate a new program translating customer support cases on their medical devices, we were able to swiftly respond by building another dedicated field team that we ourselves were able to independently train due to our accumulated knowledge and strong base of centralized content. The result? Eliminating the need for client-led instructional device training meant we were able to immediately focus on translating the important customer feedback and on gleaning key insights. This led to accelerated program deployment and high quality delivery from the start.
How did we take it one step further? With our demonstrated expertise and successful outcomes on translating support cases, we were given the opportunity to translate customer feedback on our client’s line of consumer products. Successfully paying forward the knowledge and centralized content from the medical side of the business enabled a rapid transfer to the equally important consumer side.
But the story doesn’t stop there. The insights gained from the consumer translation programs were communicated to our client’s respective global marketing teams to further leverage the input. Customer wants, needs and unique terminology is now being better reflected in all global marketing communications programs.
At the end of the day, finding new and better ways to serve customers is a shared goal, no matter the business type nor the market. It’s important to remain open as to how these new ways can be identified— and to being resourceful in tapping into the existing knowledge and assets that can be foundational to paying forward the opportunities of tomorrow.
Life sciences companies face an ongoing language challenge as their geographic footprint expands: communicating in real-time with non-English speaking individuals both inside and outside of their organizations.
Certainly, a vast amount of content produced and distributed by life sciences organizations is outside the realm of real-time communications, requiring a fully-compliant content approval process. Continue reading »
Members of the Lionbridge team are proudly exhibiting at DIA 51st Annual Conference in Washington, D.C. next week. If you’ll also be attending, we’d like to invite you to stop by Booth #1246 to discuss your global translation needs.
Here’s why it’s sure to be time well spent:
Our knowledge bridges the life sciences spectrum, from medical labeling to complex clinical content.
Recognized by Forbes as one of the 100 Most Trustworthy Companies in America, we provide translation and globalization services exclusively to Pharmaceutical, Clinical Research, Medical Device and Healthcare organizations. Take advantage of our unparalleled life sciences translation and globalization expertise in:
We recognize the critical elements at stake: sponsor relationships, clinical viability, commercial opportunity and, most importantly, patients lives.
We understand, for example, that a faulty translation can invalidate a significant portion of study data, and consider our life sciences language solutions and translation services fundamental building blocks in helping our customers achieve success.
You’ll have a chance to win a Fitbit®!
While at our booth, take part in a short survey for the chance to win a Fitbit. Two winners will be chosen at random at the end of the meeting. Results of the survey will be shared in the coming months.
We hope to see you next week in Washington!
On May 5th, we hosted a Global Communication in Life Sciences Take 30 session to discuss the pitfalls and strategies surrounding Codes of Conduct. Our panelist was accomplished attorney and ethics specialist, Anne Norris, Principal of Optimum Integrity, LLC.
While our conversation was wide-ranging, below are some of the key takeaways:
1 – A company’s Code of Conduct is the foundational building block of an ethics and compliance program. It is the vehicle through which the organization communicates its core values and high level expectations for all of its employees.
2 – If you’re taking your Code global or international, be sure to work with an experienced Language Service Provider (LSP). Your LSP will assign linguists with the appropriate background, possessing expertise in helping to manage the in-country review process. The linguists will also be able to offer superior project management to accommodate changes along the way. Be sure to keep the Code simple and visually appealing for all readers. And remember, the consequences of not having a translated Code of Conduct can be quite severe! Contact me to hear more on this.
3 – While the Code itself is the building block, companies need to identify ways to further engage their employees and promote ethical behavior. Efforts for consideration include:
Codes of Conduct are truly more than words on paper. In my opinion, they represent an organization’s ethics DNA. I was happy to be a part in this valuable Take 30. If you’re interested, read more on this topic in my Q&A post with Anne Norris here.
I look forward to your participation in our Take 30 calls in the future. Please take a moment to request membership in the LinkedIn Group today!
Regional Sales Director
Lionbridge Life Sciences
by Kelvin Chan, Head of Sales, South Asia at Lionbridge
As one of the largest annual biopharmaceutical conventions in Asia, the Biopharma Asia Meeting recently concluded its 8th program in sunny Singapore. Lionbridge was the sponsor of the opening cocktail reception, our first official participation at this high-profile convention.
Against the stoic backdrop of the nation-state mourning the recent passing of the founder of modern Singapore, Mr. Lee Kuan Yew, the event’s success was a strong endorsement of the former Prime Minister’s contributions to the transformation of Singapore’s economy. The Life Sciences sector has been earmarked one of the 4 pillars of the high-growth Singapore economy by its government for more than a decade.
The level of investment in the Life Sciences industry, and more importantly, the value that the industry brings to the human population, is second to none. Pharmaceuticals and biotechs are under enormous pressure— and deservingly incentivized— to bring safe and effective drugs, medicines and vaccines to the market as quickly as possible. It is not surprising, then, that the clinical trial space and innovations within this space that drive market acceleration, patient safety and financial efficiencies have remained hot topics at the convention over the years.
I had the opportunity to attend one of the biggest roundtables at the event: The Pan-Asian Clinical Trials Coordination, hosted by Dr. Karen Wai, Quintiles. Here are 3 takeaways from the roundtable— and the convention as a whole— on how to boost your Life Sciences business in Asia as if it were “on drugs” as they say!
1) Rely on trusted and experienced partners
2) Prioritize process consistency
3) Build a great internal corporate culture
There are no magic pills in successfully growing a regional or international business, but I hope that these 3 observations will be useful to you as you consider all your growth strategies for your business in Asia.
Last, I would like to share with you a picture of the Lionbridge team at the opening cocktail reception that we sponsored. If you couldn’t make it this year, you did miss out a great opportunity. But not to worry— we do hope to see you at the next round come 2016!
Analysts are in agreement that, while the 2014 global medical device market was a challenging year, it wasn’t a slow year. As reported in MDDOnline, Kalorama Research pegged the global market for medical devices at $361 billion in 2014, up from $330 billion in 2013.
What were some of the notable industry drivers?
Big Data is moving from back room to center stage.
Medical devices are generating more and more data, and even with regulatory and liability concerns, companies are seeking ways to utilize this valuable asset. A big contributor? Wearable technologies with $5.2 billion in global sales in 2014.
Despite the challenges surrounding increased regulations and evolving clinical standards, conducting clinical trials globally is an attractive option for life sciences organizations. But communication in clinical trials must evolve to meet the demands of the changing clinical landscape, with patient recruitment and retention communications at the forefront.
Here are 3 things to consider for improving your patient recruitment communications:
Continue reading »