What an IVD sponsor has to decide each month to have a respiratory clinical study enrolling before the season starts.
Enrollment for a respiratory IVD clinical study has to be open when the pathogen is circulating. The clinical plan, the CRO, the sites, and the specimen decisions all have to be settled months earlier.
This timeline puts the 2025 to 2026 respiratory season and the program work that precedes it on one axis, from March through the following April.
Want to talk through your season?
DCN Dx is a CRO dedicated exclusively to in vitro diagnostics, led by former trial sponsors who know how to carry a diagnostic through FDA and EU IVDR pathways with fewer surprises.
Send us your analyte mix and the season you are aiming at, and we will tell you what is still open to you.
What’s inside
- The three pathogen seasons and the program’s preparation and enrollment windows, plotted on one month axis so the two can be compared directly.
- A four-phase checklist of what has to be settled in each window: before you engage a CRO, contracting, readying the sites, and once you are enrolling.
- The CDC sources and the threshold definition used for each band.
Who it’s for
- Clinical Affairs and Clinical Operations leaders running a respiratory study
- Regulatory Affairs teams working back from a submission date
- Program and study leads deciding specimen handling against the intended claim
Disclaimer
General planning considerations from DCN Dx. Not regulatory, legal, or clinical advice, and not a substitute for your own protocol design, regulatory strategy, or consultation with FDA or qualified counsel.
