By Jenny Gidley, Vice President, Global Clinical Operations, Alberto Grignolo, Corporate Vice President, Bridget Heelan, Vice President, Regulatory and Access Consulting Group, and Amy McKee, Vice President, Regulatory Consulting Services Parexel International COVID-19 has brought with it a number of challenges in managing ongoing clinical trials for chronic, life-threatening, and rare diseases. Enrollment is slowing or even stopping in some cases to prioritize patient safety; travel restrictions are preventing in-person patient site visits and CRA monitoring visits; regulators and industry staff who once traveled widely are working from home; some IRBs are deferring protocol review meetings, and investigator sites and hospitals are justifiably prioritizing care over clinical research activities
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