The software isn't the product. The judgment is.
Diagnostica™ is our trial software, built in-house for diagnostic studies. You don't license it — it comes with every study we run.
Built for diagnostics, not bent toward them.
Generic trial software is built for drug trials and then bent, expensively, toward diagnostics. We built Diagnostica™ around what diagnostic studies actually run on — specimens, analyzers, source records, positivity, adjudication — configured around your protocol instead of asking the protocol to fit the software.
You're not really buying software. You're getting the protocol's judgment built into the work: a coordinator's second set of hands, a lab supervisor that never looks away, a protocol expert in every study — plus a compliant eTMF, EDC, and remote source capture, all 21 CFR Part 11.
Same platform. Two very different studies.
Here's what Diagnostica™ looks like when the workflow is shaped around the protocol — not the other way around.
The protocol's dosing algorithm, built into the visit.
This transplant protocol included optional, algorithm-guided immunosuppression decisions that are easy to miss in a PDF. A standard EDC only records what gets entered. Diagnostica™ builds the protocol's algorithm into the visit workflow: when a result comes in, it shows the coordinator what the protocol recommends and why. The software flags the recommendation; the clinician makes the call.
Software that supervises the lab schedule — and monitors the study in real time.
No one can hold this schedule in their head: 27 analytes with their own rules, ~50 subjects each, 138 timepoints apiece, four storage conditions, two years. So the software does the supervising — it knows what's due, flags what's slipping before it becomes a deviation, and catches an out-of-spec result the moment it lands.