Clinical trial readiness is an essential part of keeping the many people who participate in clinical trials safe while ensuring the trial runs smoothly, remains in compliance, and stays within budget.
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Clinical trial readiness has to do with building systems within a clinical trial that better prepare all project staff for the challenges and responsibilities they will face during the trial. Readiness can relate to sites, staff, and even patients — and its impact can be monumental.
The COVID-19 pandemic has forced clinical research to make bold changes to survive. Pharma Initiatives’ Mark Shapiro joined ArcheMedX to discuss what changes are temporary – and what will be true disruption.
On May 14, the FDA issued an update to its guidance on conducting clinical trials for medical products during the COVID-19 and ongoing public health emergency. Here’s what you need to know now.