First Patient In (FPI)
The trial officially begins enrollment. But feasibility doesn't stop here. It becomes an ongoing monitoring process. Are sites enrolling patients as predicted? Are screen failure rates higher than expected? Continuous tracking of these metrics against the initial feasibility plan allows for early identification of problems and rapid implementation of mitigation strategies, such as activating backup sites or launching targeted recruitment campaigns.
Monitoring enrollment rates against the data-driven forecast.
Analyzing screen failure data to identify potential issues with the protocol or site performance.
Implementing mitigation strategies, such as site re-training, targeted recruitment campaigns, or activating backup sites.
Slower-than-expected initial enrollment can jeopardize timelines.
High screen failure rates may indicate a flaw in the inclusion/exclusion criteria.
Unexpected site-level issues, like staff turnover or equipment failure, can halt progress.
Use the AI tool to check a sample dataset for errors, simulating the kind of analysis needed during an active trial.
Analyze Sample Data Quality