IVD trials don't look like drug trials. Data comes from multiple independent labs, each with its own formats and turnaround times. Samples have to be tracked across sites. Analytical validation (sensitivity, specificity, reproducibility, limit of detection) needs tight coordination between clinical and lab teams. And timelines are short, because the market won't wait.
Most diagnostics companies still manage all of this with separate tools: a basic EDC, spreadsheets for site tracking, shared drives for documents, and a standalone safety database. The result is manual reconciliation, slow site start-up, missing documents at inspection time, and study leaders who find out about enrollment or sample problems too late to fix them.
| Number | What it means |
|---|---|
| 80–90% | Share of IVDs that now need Notified Body oversight under EU IVDR, up from about 20% under IVDD |
| 40% | Reduction in site start-up time after one diagnostics company moved to a unified platform |
| 30% | Improvement in data entry-to-verification cycle times |
| 3 months | How far ahead of schedule the same company submitted its CE marking dossier |
| 0 | Major findings in the company's regulatory inspections after the switch |
Results from the mid-sized infectious disease diagnostics company profiled in the whitepaper.
Under IVDR, most IVDs now need Notified Body review, and the evidence has to hold up not just at launch but across the product's lifecycle. Meanwhile, competitors are moving fast in infectious disease, oncology, and companion diagnostics. The companies that get to market first will be the ones whose clinical operations, lab data, and documentation already live in one place, ready for regulators at any moment.
Unify your IVD trials. Get to market faster. See how one diagnostics company cut site start-up by 40% and filed early.