COMPLYING WITH THE ICH E6(R2) ADDENDUM
Six steps to ensuring risk-based quality management in clinical trials
Taking a centralized, proactive approach to risk management delivers clear, measurable benefits to sponsors and CROs. With ICH (E6) guidance laying out a mandate for compliance, sponsors need to take action now. Use this guide to better understand the guidance and its implications, as well as our recommendations on how to get started on the path to compliance success.
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