Contributed to PharmaLeaders by Authors: By Ana Bargo, M.S.; Jeannine Cain, MSHI, RHIA, CPHI; Shannon Fee, B.A.; Mark Yap, FNP-C In 2016, a major transformation occurred in how we evaluate clinical data for real-world effectiveness. The FDA signed into law the 21st Century Cures Act, which impacted the Real-World Evidence Program in the U.S. It signaled a paradigm shift in … [Read more...]
Five Ways Study Sites Benefit from Remote Monitoring
Authored and contributed to PharmaLeaders by Jeff Pool, VP of Revenue at Florence Healthcare Failed remote site access and monitoring attempts have left study sites with a computer full of access portals, FTP logins, document vaults, and emails. Why do sponsor remote site access and monitoring rollouts fail? Because the sponsor focuses on solving their access problems – … [Read more...]
Going Virtual
Contributing Author: Chris Mycek, President at WORLEY Pivoting to virtual….Google it, you’ll find it’s a common current theme that will have enduring repercussions on how things get done. Zoom is a new household word, and now a verb as well. Amazon Prime, Netflix, FedEx, are all booming. Nesting at home, with new entertainment centers, pools, and other home luxuries are also … [Read more...]
Balancing Innovation and Risk Management in Biopharma Commercialization
RxC International’s whitepaper is designed to bring the reader’s attention to the value of innovation and risk management in biopharma commercialization. The authors present several important trends that profoundly impact the commercialization of novel treatments. These trends include the changing landscape of value-based healthcare, consumerism, personalized solutions, … [Read more...]
COVID-19 Accelerates Digital Transformation in Life Sciences
Author: Andy Fuchs, VP of Commercial Strategy, Veeva Systems Public safety is the world’s singular goal as mandatory quarantines, shelter-in-place orders, travel restrictions, and mandatory work-from-home policies go into effect to curb the spread of COVID-19. In response, many biopharmaceutical companies are shifting how they work: Amarin withdrew part of its field force, … [Read more...]