How DCN Dx Helped a Sponsor Launch Mid-Season, Hit Enrollment Goals, and Submit on Time
This case study tells the story of a sponsor who developed a multiplexed respiratory test intended for over-the-counter use—only to face delays that pushed the study launch into the middle of respiratory season. With FDA enrollment targets looming and time running short, they turned to DCN Dx to make it happen.
The DCN Dx Clinical Research Services team activated nine sites, tracked real-time positivity rates, and responded to mid-study FDA changes that altered enrollment requirements. Despite starting late in the season, DCN Dx delivered the data needed for a successful EUA—and enough additional data to support a future 510(k) submission, all without reopening enrollment.
This case illustrates the level of planning, flexibility, and execution required when there’s no margin for delay.
WHY READ
If your study timing is less than ideal, this case study shows how DCN Dx can help:
- Launch respiratory or seasonal studies mid-cycle without missing key data targets.
- Adapt to shifting regulatory requirements in real time.
- Manage complex, multi-site studies under tight timelines.
- Optimize enrollment strategies based on live data monitoring.
- Deliver complete study packages that support both EUA and 510(k) submissions.
