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.
Mobile Visits in Decentralized Clinical Trials: The Past, Present and Future
May 7th 2024In March 2024, the US FDA issued its guidance, “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” outlining the agency’s objectives for protecting public health as artificial intelligence (AI) and other technologies become more prevalent in healthcare.
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.