FDA Releases Guidance on Formal Meetings Amid COVID-19 Crisis
The FDA announced on Wednesday (5/27) new guidances via a Q&A format for how COVID-19 is impacting formal meetings, effective immediately. The guidance outlines that all meetings with the FDA will be held remotely, either through teleconference or video...
Interviewing CSOFT Health Sciences Strategy Advisor, VP Region Head Medical Amgen, Professor Victoria Elegant
CSOFT Health Sciences and Professor Victoria Elegant convened for another conversation after her previous Women’s day interview (here). She has been actively involved in managing the COVID-19 pandemic situation with her staff. She recently was a panelist on a MAPS...
Remote Devices: A New Age of Patient Centricity
A new age of patient centricity has dawned, and the need for remote patient engagement has become more crucial than ever. From being able to remotely visit COVID-19 patients, to continuously tracking patients participating in clinical trials, remote technology helps...
How Real-World Data and Real-World Evidence Are Revealing the Patient’s Untold Story
As our world is constantly changing, the healthcare industry is adapting to better serve patients and improve lives around the world. While healthcare is shifting to become more patient-centric, additional data from the patient’s day-to-day life is needed to enhance...
Exploring the World of Vaccinations
Explore the world of vaccinations with Professor K in understanding what they are, how they work, and the challenges they face in development and implementation, especially for COVID-19.
Amazing Cooperation Between Companies to Meet Global Demands for Pandemic-Response Equipment
There has been amazing cooperation by companies with global supply chains to come together and produce surplus PPE and ventilators for domestic and international markets. Communicating effectively across multi-lingual global supply chains is more important than ever...
A Tale of Global Pandemics
This article is part 1 of a mini-series focusing on the progression of global pandemics. This instalment explores the history of past pandemics and how they relate to the current COVID-19 situation. While it may seem that our current self-quarantine has brought upon...
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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
