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This 3-part series provides insight into ensuring compliance with the ICH E6 (R2) Addendum to take effect later this year. Part 2 covers steps that organizations can take today to begin adopting a centralized technology-based approach to risk management.
This 3-part series is designed to outline the implications and processes for ensuring compliance with ICH E6 (R2) changes that are scheduled to go into effect late 2016. For an overview of the Addendum see Part 1 of the series, published here on June 6, 2016. Part 2: Six steps to compliance with ICH E6 (R2) Addendum The ICH’s new E6 (R2) addendum to Good Clinical Practice has the potential to change the way clinical monitoring and trial management are conducted by requiring adoption of centralized, quality risk management (QRM) throughout the trial lifecycle. Trial sponsors and CROs recognize real, measurable benefits from taking a centralized, technology-based approach to risk management. These include reduced on-site monitoring costs, real time identification of risk trends across all trial sites and access to trial-wide views that enable them to capture best practices for future trials. However, sponsors and CROs have been slow to adopt this centralized approach, likely because it requires some culture and technology transformation which can be difficult for some organizations to undertake. But the ICH addendum will soon be required, so companies need to start taking steps today to ensure compliance and to reap the time and cost savings benefits that come from a centralized technology-based approach to risk management. Here’s how:
Look for Part 3 of the series next week: ‘Driving Compliance through Technology: Act Now’
Nick Neri is the Insights Cloud Platform Manager for ERT