Has your clinical trial program gone astray? Are you missing important goals and milestones? Is there a lack of communication and support for your trial? Are you worried about your clinical program?
Take a deep breath. Everybody needs a little help sometimes. We know there are so many moving parts in a clinical trial, and there’s always a risk of missing timelines, budget constraints, data quality, or regulatory standards. Perhaps your current team is not achieving the necessary milestones, or you’ve received regulatory direction to make adjustments in your protocol.
In some recent studies, sponsors are finding that their compounds escalate from early– to late-phase faster than expected, and their current team is caught unprepared for the accelerated timeline. When your project needs to be transitioned, it’s critically important that intervention is swift to keep your study within its timelines, while at the same time maintaining regulatory compliance and high data quality.