Tag: R&D

CASE STUDY: ENSURING REGULATORY COMPLIANCE | ICH E6 (R2) Addendum | Optimizing Quality Risk Management

INDUSTRY CHALLENGE AND OPPORTUNITY: The recently revised ICH E6 (R2) Addendum provides both a challenge and opportunity for GCP organizations to modernize their QRM approaches.  By building quality in – starting with critical data & processes during  protocol development, using centralized and study risk-based monitoring, strengthening risk mitigation – organizations...

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