Remote Enrollment in a Non-Significant Risk Device Study
While the FDA has issued guidance to help sponsors, investigators and IRBs decide on the best ways to protect patients while keeping their trial moving, the decision is ultimately up to each individual research team. IMARC has assisted research teams with remote monitoring, auditing and other activities for years. More recently, our team helped one company transition to an entirely remote clinical trial. We wanted to share this example to show it can be done, under certain circumstances and with careful consideration.
Digital Biomarkers Solution shows pathway to reduced clinical trial sample sizes, shorter durations
April 5th 2024Digital biomarkers provide a pathway to the future where clinical trial sponsors can potentially benefit from reduced trial duration and sample size. Learn more about these benefits from a simulated study.
