When the entire chapter on "Monitoring" and "Auditing" has almost disappeared from the new GCP, how should Sponsors respond? This is not a regulatory retreat, but a profound shift ...
With the further implementation of the new GCP, the central figure in clinical trials—the Principal Investigator (PI)—is facing more defined and stringent responsibility guidelines. The chart below ...
In our previous issue, we decoded the evolution of core terminology in the 2025 draft GCP, revealing a transformation in underlying principles. This time, we turn our focus to the "gatekeeper&quo...
In the previous issue, we provided a macro-level analysis of the structural changes in the 2025 draft GCP (solicitation for comments), highlighting the evolution of the regulatory framework toward a &...
We are excited to launch our "GCP Insights – 7-Day Series", a deep dive into China's newly released "Drug Clinical Trial Quality Management规范 (GCP) 2025 Draft for Comments",...
Feeling overwhelmed by the complexities of clinical trial management? Our phase-specific GCP guidelines provide clear roadmaps for every stage, transforming uncertainty into actionable strategies. ...
