Thought Leadership
Blog & Article
- 19th June 2025
Blog & Article
- 12th June 2025
Blog & Article
- 27th May 2025
Journal Article
This article assesses some of the most notable clinical developments in recent years, where the next generation of research is likely to be heading in the coming years, how the regulatory authorities are responding to these advances, and how these developments and regulatory proposals are likely to impact patient access.
Journal Article
Regulators are tightening their scrutiny of the trial master file (TMF), placing the onus on companies to be ready for evaluation. Inspection-readiness should be embedded from the beginning, rather than a reaction to a notice of an inspection.