For most companies, Q4 is focused on competing priorities between the time that’s necessary to support planning initiatives and ensuring compliance standards such as ICH E6 R2 are being implemented and thoroughly managed. ICH E6 R2 serves a critical purpose – in summary:
“The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).”
Harbor Clinical is actively engaged with several of our sponsor partners setting up their 2020 vendor, site, and internal audit calendar. The proactive measure makes the process seamless and demonstrates a level of oversight. Applying our expertise and experience, we’re able to ensure clinical trial planning and implementation stays on track without unexpected interruptions, and the peace of mind of knowing ICH E6 R2 guidelines are being met. For your convenience, we’ve compiled a quick video demonstrating the level of service you can expect from the Harbor Clinical team:
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