The Device Trial
Enrollment Checklist
Most device and diagnostics teams are managing around their tools more than they should be — manual re-consent tracking, enrollment data living in spreadsheets, site activation that takes longer than it needs to. The gaps tend to show up mid-study, when it’s already too late to course-correct without extending the timeline. This checklist helps you find them before your next study does.
- Whether your enrollment pipeline is actually visible in real time — or only in retrospect
- Where re-consent workflows break down when device designs change mid-study
- What site activation friction looks like when your platform wasn’t built for device workflows
- Whether your current study system can carry you from first-in-human to post-market without switching platforms
- VPs and Directors of Clinical Operations managing device and combination product studies
- Clinical Data Managers running device studies in-house
- Regulatory Affairs leads responsible for consent compliance and audit trail integrity
- CRO project leads focused on device or combination product trials
Download the checklist to find out if you have any gaps — and see what a study system built for device workflows actually looks like.
