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...
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...
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...
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...
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....
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...
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...
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...
Today (5/18) Moderna announced that its Covid vaccine clinical trial in the United States has started to see protective antibodies in data from 8 healthy individuals, chosen at random from a 45-person study. The study, which began in March, and found that the...
Marco Cavaleri, the European Medicines Agency’s (EMA) top official overseeing anti-infectives and vaccines, acknowledged the potential for a Covid vaccine to be ready by Spring 2021 during a virtual conference last Thursday (5/8). He says that while there may be...
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