ICH E6 (R3) introduces a dedicated section on data governance, reflecting the increasing complexity of data sources and systems used in modern trials. Sponsors are expected to maintain oversight of ...

Over the past 20 years, courts have clarified that clinical practice guidelines are helpful but not definitive standards of care. They can be used by experts as part of their reasoning but are not ...

Opportunities center on delivering comprehensive GCP training that covers recent regulatory updates, the EU Clinical Trials Regulation, and ICH GCP R3. Interactive courses that address new tech in ...