Advarra Launches Study Design Solution, Powered by Braid, to Improve Operational Efficiency in Clinical Trials — Read the Press Release

Education

regulation, regulatory framework, compliance with regulations, regulatory standards, regulatory authorities, government regulation, industry regulation, financial regulation, regulatory policy, regulatory reforms, regulatory oversight, regulatory requirements, regulatory guidelines, regulatory reporting, regulatory enforcement, regulatory changes, regulatory implications, tile, word, letter tiles, background

Are you prepared for ICH E6 (R3)?  

The third revision (R3) of the ICH E6 Guideline for Good Clinical Practice represents a significant modernization of global clinical research standards. Research organizations must critically evaluate both their clinical priorities and operational procedures to ensure compliance.

The Executive Order that Brings Private Bioresearch Under Federal Oversight

The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. More than a revision, E6(R3) marks a shift from traditional practices—making participant safety and data reliability not just priorities, but design drivers, and introducing risk-based proportionality as a foundational approach.

A digital interface showing a person interacting with transparent virtual icons related to compliance, such as "Policies," "Regulations," "Audit," "Guideline," "Requirement," and "Law." The word "COMPLIANCE" is prominently displayed in the center, surrounded by hexagonal icons representing various regulatory and legal concepts.

ICH E6(R3) Implementation Starts Now: Are You Ready?

The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. More than a revision, E6(R3) marks a shift from traditional practices—making participant safety and data reliability not just priorities, but design drivers, and introducing risk-based proportionality as a foundational approach.

Scroll to Top