IMARC Research

Every successful clinical trial must protect patients while collecting complete, accurate data that supports evaluation of the safety and effectiveness of the drug or device. Here’s a closer look at why data and safety managers are so important to a clinical trial, what can go wrong when they aren’t aligned and how to improve collaboration between them.

Join us to discover how you can keep your clinical trials moving forward in the midst of the COVID-19 pandemic, using creative strategies such as remote enrollment, monitoring, and data management. Hear real-life examples and discover how to apply these strategies to ongoing studies, as well as how to incorporate them into future study plans. Live: Wednesday, Sept. 16, 2020 at 2pm EDT | 1pm CDT | 11am PDT On demand available after airing until Sept. 16, 2021.

With new technology and groundbreaking medical devices being introduced every week, there’s never been a more exciting time to be involved in clinical research. Even during the coronavirus pandemic, the pace of innovation has only accelerated. 

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.

To help research sites prepare for BIMO inspections, the FDA provides standard guidance to review, as well as BIMO Inspection Metrics detailing the most common findings by fiscal year.