With the aim of improving efficiencies in trial conduct while ensuring participant safety, regulatory guidelines have recently undergone revision. The revision to the ICH Guideline for Good Clinical Practice (E6 R2) primarily addresses quality management with a focus on risk identification, evaluation, control, review and reporting. With the pending adoption of these revised guidelines, it's time to evaluate how your organizational structure and processes will be affected.

Download our white paper to learn more about:

• The changes to the guideline, particularly regarding how they affect quality management and risk-based monitoring
• Suggestions for interpreting the guidelines and how they specifically affect your organization
• Considerations when implementing the guidelines