As clinical trials step into the digital age, data governance has become a core element in ensuring trial quality. By introducing a completely new [Data Governance] chapter, GCP 2025 establishes syste...
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",...
