AI GxP validation for regulated life sciences
Study Intelligence · Sites, visits and milestones

See how each study is really running, across every vendor.

Enrolment, visits, sample collection, protocol deviations and vendor milestones in one operational view, tied back to the sample and biomarker data.

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

Study Operations Intelligence shows enrolment, visits, expected and received samples, protocol deviations and vendor milestones for each study in one view, linked to the underlying sample and biomarker records, so study managers can see where a study is behind and why without assembling reports from each CRO.

The problem

Oversight assembled by hand

Sponsor oversight of outsourced studies often means weekly reports from each vendor in different formats, reconciled by hand into a status deck that is out of date by the time it is presented.

How Study Intelligence handles it

Expected versus received

The schedule of assessments tells the system which samples each visit should produce. Missing, late or unexpected samples are visible by site and by visit as soon as the data arrives.

Vendors on one page

Each vendor's milestones and open items are tracked in one place, and a study agent can summarise what is outstanding for a vendor call.

Deliverables

What you get

Enrolment and visit status by site
Missing and late samples visible per visit
Protocol deviations linked to the affected data
Vendor milestones and open items in one view
Summary

What Study Operations Intelligence delivers

Study Operations Intelligence 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 Agents.

clinical operations analyticsstudy management softwareclinical trial oversightsite performance tracking
  • Enrolment and visit progress by site
  • Expected versus received samples per visit
  • Protocol deviations linked to subjects and samples
  • Vendor milestones and outstanding items
FAQ

Common questions

Prefer to talk first? Chat with us on WhatsApp or book a call with an expert.

Does it replace our CTMS?

No. It reads from the systems you already use, including your CTMS and EDC exports, and links operational data to samples and biomarker results.

See study operations intelligence 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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