Translation Memory and Maintaining Your Investment
Translation memory tools first appeared commercially in the in the early 1990s. It served as a unique method to increase translation productivity…
Localization Industry Trends: A look at LocWorld35
LocWorld35 Silicon Valley kicked off yesterday with the preconference program, this leading conference in the language and localization industry…
Innovation: A Top Priority for the Life Sciences Industries
Yesterday, FDA Commissioner Scott Gottlieb made a statement on the new steps that the FDA is taking to improve innovation in medical devices…
The Real Challenges and Pitfalls of Machine Translation
I found a really interesting article this week, that I thought was worth bringing up. It is based on a study of phrases utilized in clinical settings, and the effectiveness of a free machine translation to bridge communication gaps between patient and caregiver....
China Announces Change to Clinical Trial Requirements
Earlier this week, China's State Council announced plans to allow clinical trial data from other countries. As one of the largest pharmaceutical markets in the world, they are looking to bring in new, innovative therapies quicker. This comes on the heels of changes...
Tips for Establishing and Maintaining a Quality Management System (QMS)
Let's talk about quality! When it comes to translation there are two types of quality, the end product that is being delivered and the process it goes through to get there. Today we are going to look at the latter. Quality management systems, used by industries...
Book A Translator Service for the Life Science Industries
As we have discussed before, translators are increasingly being used in clinical settings. Utilizing interpreters, whether via phone or in person, enables patients or clinical trial participants to fully grasp information given to them. This allows clinicians to...
Medical Device Quality and ISO 13485:2016 Certification
Published in 2016, ISO 13485:2016 is in its third edition. ISO 13485:2016 comes on the heels of the ISO 13485:2003. Beginning in March 2016, there is a three-year transition period which comes to an end on February 28th 2019. These regulatory requirements undergo...
Man vs Machine Translation: The Continued Debate
Quite a while ago we took a look at the role of machine translation (MT) in life science translations. It's a hot topic of debate, and we can all see with a quick internet-based translation what the pitfalls are. These one-off quick translations of a block of text...
Looking at Healthcare Needs for an Aging Population in Japan
Earlier this month we were looking at some of the factors affecting the life science industries today. Undeniably, the world’s aging population is changing the priorities of health care delivery and infrastructure all over the globe. With an older population, there's...
The Evolving Regulatory Environment in Japan (PMDA)
At DIA in June of this year, Tatsuya Kondo, Chief Executive of Pharmaceuticals and Medical Devices Agency (PMDA) gave a presentation on the future activities of the PMDA in Japan. In the presentation, Kondo discusses Japan's "Rational Medicine" Initiative. This...
The Evolving Landscape of Life Science Translation
The life science sector is continually evolving and becoming ever more globalized. What used to work as a business model is progressively challenged by cost pressures, operating performance challenges as more mergers and acquisitions take place, and global trends in...
Rounding Out the Summer: Industry Events
As summer is quickly drawing to a close, I want to take this time to explore some of the many upcoming industry events. In such a fast-paced industry, the life sciences industries are an area that provides numerous opportunities for continued learning. Understanding...
CFDA Reform Scheme of the Classification System for Registration of Chemical Drugs
On March 4th of 2016, the China Food and Drug Agency (CFDA) officially launched their new classification system for chemical drugs. Under the Reform Scheme of the Classification System for Registration of Chemical Drugs (Reform Scheme), previously called the Drug...
Regulatory Submissions: FDA (US) Requirements for CDISC Standards
Beginning in December of last year, all clinical trials are required to adhere to CDISC Standards. The Clinical Data Interchange Standards Consortium (CDISC) is a global not for profit organization with a mission to develop global standards. Through standardized...
e-Learning in the Life Sciences Industries – Best Practices
In our digitally connected world, e-Learning is being used ever more frequently as a method of information delivery. Utilized by industries around the globe, e-Learning allows for efficient and cost-effective continued learning and training opportunities. Localizing...
Can Machine Translation Be Used in Life Science Translations?
Machine translation (MT), I know what you are thinking when you hear that phrase. Machine translations translate words not language. While that may be true, machine translation is making leaps and bounds over the last few decades. People are using machine translation...
CFDA: The Face of Regulation in China
The China Food and Drug Administration (CFDA) was founded in 2013. Grown from the organization formally known as the State Food and Drug Administration (SFDA), the CFDA was created to combine multiple regulatory authorities into a singular regulation process for food...
Why an In-Country Review (ICR) is So Important
An in-country review (ICR), also referred to as an in-house review, is an essential step in life science translations. With translations for industries such as medical, pharmaceuticals, and biotechnologies, accuracy is of the utmost importance. Generally, in-country...
Clinical Trials in India
Several years ago, clinical trials in India were a booming business. After becoming fully compliant with TRIPS in 2005, India was seen as a favorable place to conduct clinical trials as they boast a huge genetically diverse population, as well as a multitude of...