data/summaries/regulations_standards.txt

Regulatory frameworks are reinforcing this shift. ICH E8(R1) emphasizes Quality by Design and focusing
on Critical to Quality factors. ICH E6(R3) promotes proportionate, risk-based trial conduct and integration
of digital technologies. Standards like CDISC remain vital. Regulators no longer encourage rigid,
uniform processes. Instead, they want fit-for-purpose approaches that prioritize patient safety and reliable
results. Data governance, integrity, and privacy are central regulatory expectations.