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.
Johnson & Johnson to Begin Human Trials of Covid Vaccine in July
Johnson & Johnson announced today (6/10) that they will be initiating human trials in the second half of July for the Covid vaccine. The trials are expected to last over the course of two months in both the United States as well as Belgium, and will be...
WHO Prequalifies Rituximab Biosimilar for Cancer Treatment
The World Health Organization (WHO) has prequalified a biosimilar of version of rituximab, which is used to treat certain cancers and autoimmune diseases, created by Celltrion. This drug therapy is the second to achieve prequalification status under the...
Key Factors Driving Medical Writing Outsourcing Strategy – II
CSOFT Health Sciences SVP Dr. Nimita Limaye joins us once again to continue her interview on Key Factors Driving Medical Writing Outsourcing Strategy. This time, she focuses on the importance of alignment in terms of business operations, business models and...
Interviewing Dr. George King, Chief Scientific Officer and the Founder / Director of Asian American Diabetes Initiative (AADI) at the Joslin Diabetes Center, affiliated with Harvard Medical School
CSOFT Health Sciences is interviewing Dr. George King, MD at Harvard Medical School’s Joslin Diabetes Center. As the Chief Scientific Officer, a Senior Vice President, and the Founder and Director of the Asian American Diabetes Initiative (AADI), Dr. King is well...
FDA Releases MyStudies App for Patient Informed Consent
The FDA released the app FDA MyStudies, which can be found in app stores as COVID MyStudies, for patients to provide informed consent for traditional clinical trials, real-world trials, observational studies, and registries. The app is free, as...
The United States Grants $628 Million Contract with Emergent for Covid
Due to the Covid pandemic, The Department of Health and Human Services granted Emergent BioSolutions a $628 million contract under the Biomedical Advanced Research and Development Authority (BARDA), a U.S. federal agency that funds disease-fighting technology in...
FDA Releases Guidance on Formal Meetings Amid Covid Crisis
The FDA announced on Wednesday (5/27) new guidelines via a Q&A format for how Covid is impacting formal meetings, effective immediately. The guidance outlines that all meetings with the FDA will be held remotely, either through teleconference or video conference....
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 interviewing her for Women’s day (here). She has been actively involved in managing the COVID-19 pandemic situation with her staff. She recently was a panelist on a MAPS...
EMA Strengthens ENCePP Mandate Due to Covid
Due to Covid, the European Medical Association (EMA) has strengthened the mandate for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Currently, the mandate works to strengthen how the risks and benefits of medicinal products...
Remote Devices: A New Age of Patient Centricity
A new age of patient centricity has dawned, and the need for remote patient engagement and remote devices has become more crucial than ever. From being able to remotely visit COVID-19 patients, to continuously tracking patients participating in clinical trials, remote...
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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