Clinical Research and GCP Update

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Are you ready for the period post-pandemic?

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What were the challenges?

• Protecting trial participants and site staff • Quarantines, travel limitations • Site closures • Those involved become infected • IMP supply chain limitations and interruptions • Difficulties meeting protocol requirements − Protocol violations/deviations • Lab testing difficulties • Ability to monitor and oversee study conduct

• Missing data, data integrity • Safety reporting deficiencies • Postponed audits • Remote inspections

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© Brookwood Global (Canary Ltd) 2021

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