Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.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...
Resources for Translators and Interpreters in Life Sciences
Do a quick search and you will discover a plethora of websites and articles filled with information for translators and interpreters in the life sciences. One of the principal challenges of translating for life sciences is the highly scientific terminology and lexicon...
Navigating Social Media for the Life Science Industries
There is no denying it, social media and its impact on the way we interact on the web is a growing presence. As consumers, we regularly take to social media to share our lives and connect with others. Whether for praise or to complain, we want our voices heard. Life...
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ABOUT US
CSOFT Health Sciences has over 15 years of experience providing end-to-end translation and localization solutions for all stages of the product life cycle, from pre-clinical to post-launch. We also specialize in China market access consulting services, Asian regulatory and eCTD submissions. Our operation is compliant with ISO 17100 and certified by BSI in ISO 9001:2015 and ISO 13485:2016, providing customized solutions to meet the rigorous regulatory requirements in global submission. For more information, please visit: www.csoftintl.com