Insights on FDA Inspections of APAC Clinical Trial Sites and Their Quality Improvements
- FDA inspection findings indicate that quality issues at APAC clinical trial sites are comparable to those in the US and Europe.
- China has significantly reduced approval timelines for clinical trials, now averaging six and a half months, with some reviews taking as little as 30 days.
Operational Impact
Smaller biotechs must adapt their strategies for APAC Phase III trials, focusing on site selection and partnering with experienced CROs to leverage faster recruitment and lower costs.
Source: Applied Clinical Trials RSS