Reads that become regulatory evidence
The client builds AI triage software that alerts radiologists to urgent findings. One of the conditions it targets is the intracranial aneurysm — life-threatening if missed, and small enough to be easy to overlook.
To support an FDA submission, the client ran a multi-pathology programme in which every condition is evaluated in two separate rounds by independent radiologists. Every decision made in those rounds becomes part of the evidence package, so reviewer credentials, reviewer independence and the documentation behind both had to withstand regulatory scrutiny.
The reviewer profile was narrow: practising, US-based neuroradiologists with ABR certification and substantial CT reading experience. The reading window was two weeks.
Referrals from the network, not cold outreach alone
Medcase asked trusted neuroradiologists already in its network to recommend qualified peers, and ran targeted outreach in parallel. Every candidate was checked against the client's certification criteria before being proposed.
Three new senior neuroradiologists were approved and ready to read in under a week. At this level of sub-specialisation, that is the difference between a two-week window being feasible and not.
One point of contact for both sides
Medcase sat between the reviewers and the client for the length of the study, resolving protocol questions as they came up so that no reviewer was left guessing and no question waited on a scheduled call.
A contingency agreed before it was needed
When one reviewer's clinical commitments put the timeline at risk, Medcase reached them through every available channel and, in parallel, agreed a contingency with the client: reassign the remaining cases to an experienced backup neuroradiologist if the original reader could not finish. The client was kept informed at each step.
The contingency was not needed. Every read was delivered on schedule and the study closed as planned — which is the point of having one.
Both rounds, same operation
Medcase staffed and ran both review rounds of the brain aneurysm evaluation, handling recruitment, onboarding, scheduling and progress tracking end to end. Every case was delivered with full documentation, so the client's team could stay on its submission rather than on reviewer logistics.
Study volume and reading pace
Work package | Count |
|---|---|
CTA scans read | 265 |
Readers per scan | 3 |
Independent expert reads | 795 |
New neuroradiologists recruited and approved | 3 |
Total expert hours | ~48 |
Average time per read | ~3.6 minutes |
Reading window | 2 weeks |
Review rounds staffed by Medcase | Both |
Results: 795 expert reads, no adjustments at review
- 265 CTA scans, each read independently by all three neuroradiologists — 795 expert reads in total.
- Three new senior US neuroradiologists recruited and approved against the client's certification criteria in about a week.
- Roughly 48 expert hours, averaging about 3.6 minutes per read, inside the planned range.
- Every read delivered within the two-week study window.
- The client confirmed that no adjustments were required at review.
- Both review rounds of the brain aneurysm evaluation staffed by Medcase, supporting the client's FDA submission.