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Inspection Readiness Fact Sheet

Aperio Clinical Outcomes has extensive experience in managing inspections for regulatory submissions and addressing the requirements of multiple regulatory  agencies, including FDA, EMA, MHRA, BfArM and DEA. Tony Bumarch, VP Global Quality Assurance, has held senior QA roles for both sponsors, sites and CROs and has been a part of more than 10 agency inspections for regulatory submissions.

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Aperio Clinical Outcomes offers essential services for today’s complex, data-intensive oncology and rare disease clinical trials: rock-solid fit-for-purpose database development and management, unmatched analytics expertise, and powerful holistic tools that deliver the most coherent and actionable views of essential data. Just as important, in an industry flooded with promises, we make only one: We tell the truth, no matter what.

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