AI GxP validation for regulated life sciences
Study Intelligence · Consent, custody and stability checks

The problems that become audit findings, raised when they happen.

Continuous checks for consent withdrawals with samples still in use, broken chains of custody, stability windows, missed shipments and samples with no matching visit.

Study Intelligence: Exception Detection
Answers with sourcesEvery record cited
Human reviewBefore anything is approved
In short

Exception detection checks study data continuously for the issues that turn into audit findings: samples from subjects who withdrew consent, breaks in chain of custody, samples near their stability limit, shipments that were sent but never received, and samples or results with no matching subject or visit. Each exception goes to a named owner with the records attached.

The problem

Found at the audit, not when it happened

Consent and custody issues are usually found late, when a sample has already been tested or shared. At that point the fix is a deviation and an explanation rather than a simple correction.

How Study Intelligence handles it

Raised to an owner

Each exception type has an owner and a due date. The exception carries the records that caused it, so the owner does not have to rebuild the picture.

Deliverables

What you get

Consent issues raised before samples are used
Missed shipments visible within days
Stability risks flagged ahead of the limit
Every exception assigned and tracked to closure
Summary

What Exception Detection delivers

Exception Detection is part of the Study Intelligence platform — an AI-native, study intelligence system built for regulated Life Sciences. See how it fits with Sample Intelligence, Biomarker Data Intelligence, Study Operations Intelligence.

clinical trial exception managementsample consent trackingchain of custody monitoringstability window tracking
  • Consent withdrawals with samples still stored or in testing
  • Broken chain of custody
  • Samples approaching stability limits
  • Shipments sent but not received
FAQ

Common questions

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Can we add our own checks?

Yes. Study-specific checks, such as protocol-defined sample windows, are configured during onboarding.

See exception detection on your own data.

Bring a study's sample manifest or vendor data. We show you the reconciled view and the questions it answers.

  • We reply within one business day
  • We walk through a study like yours
  • You see answers with their sources

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