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Aim: To have all SAEs closed and
Quality Checked within the next 4 weeks.…
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Aim: To have all SAEs closed and
Quality Checked within the next 4 weeks.
Study closure.
Note: The client has pulled forward study closure deadlines by 1 month.
Problems
External problems
External problems
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Client not clear on deliverables, timelines, and it is difficult to obtain clarification with regard to process; changes process and deadlines frequently.
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Current Project Status - behind schedule:
SAE events received 6 months ago remain open.
79% of the 400 SAEs remain open with the process.
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Internal problems
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Poor leadership
Issues were not escalated in a timely manner, The problems within the PVG team and other issues were not handled appropriately.
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