Skip to main content
Once a problem is detected, we must ensure that it is documented, along with its associated actions and resolutions.
For starters, centralized monitoring is not a one-person function.
Scott Gottlieb, the new head of U.S. FDA, has suggested he will promote wider use of adaptive design, and Abi Millar at Pharmaceutical Technology examines whether pharma companies are willing to make the changes to both infrastructure and mindset to allow for more flexible protocols.
As the FDA and other regulatory agencies embrace new clinical development approaches, how do sponsors and CROs promote new innovation while staying regulatory compliant?
China is one of the most dynamic markets for clinical development. We had a chance to catch up with Helena Zhu, director of clinical development at Chinese pharma company Hansoh Pharmaceutical, at our China Symposium in Shanghai to discuss the ever-evolving Chinese market.