AQ Platform combines document intelligence, study assessment and drafting assistance to reduce administrative effort and support informed decisions across studies and sites.
Revised procedures, protocol amendments and storage excursions affect related activities. AQ identifies those connections and assembles the information needed to plan a coordinated response.
Each draws on records held in several modules. A tool scoped to one of them produces one part of the answer.
Outstanding requirements and emerging issues appear alongside source records, assigned reviewers and current status, providing the context needed to assess priorities and coordinate follow-up.
BREEZE-2 · 5 sites · Items needing attention4 openIllustrativeIndividually each was closed locally. Together they suggest the procedure rather than the site is the cause.
The milestone cannot be marked complete, and the study is scheduled to move to Conduct this month.
Eleven of the seventeen hold delegated tasks that reference it.
The consignments are held pending assessment.
Illustrative, fictional data.
Why the first item matters · deviations by site, last 8 weeksIllustrativeNo single site’s record contains the pattern. It appears only when the deviations, the corrective actions and the procedure are read together.
Document classification, readiness assessment, drafting and evidence retrieval draw on information already held within AQ Platform, reducing the preparation required for routine study activities.
Document intelligence · BREEZE-2IllustrativeAQ reads a document on arrival and proposes its classification and the expected-document entry it satisfies, with the version and signature requirements for that entry. The site file owner confirms or corrects the placement.
Where a check runs on a configured rule rather than a model, AQ describes it as automated. Illustrative, fictional data.
Evaluate the information each feature uses, the task its output supports, the authority required for approval and the evidence retained for subsequent examination.
Related deviations, corrective actions, procedures and training records are assessed together to highlight patterns that warrant investigation and consideration of their wider impact.
Quality signal · Consent version not current at visit · 3 of 5 sitesIllustrativeAQ raises the flag and supplies the records behind it. The assessment and its reasoning are the quality lead’s.
Expected documents, versions and signatures are checked alongside relevant training and delegation requirements, highlighting information that is missing, outdated or incomplete.
What the file should hold at this point in the study.
Whether the filed version is current and signed.
Whether required training is assigned and complete.
Whether the person is delegated and the delegation is current.
One gap, read against two records · BREEZE-2 · Riverside TrustIllustrativeThe expired CV is a missing item in eISF 02.03, sitting in a queue of documents to chase.
Consent is being taken this week under a delegation whose supporting requirement has lapsed.
AQ Assist retrieves and summarises accessible study information, providing references and identifying missing information so the response can be examined in context.


Eight items are outstanding against the visit, two of them overdue. The three below gate the visit; the remaining five are listed in the readiness view.
Illustrative, fictional data. Interface shown as in AQ Platform.
AI suggestions follow the applicable review and approval process, with supporting sources, reviewer details and decisions retained, including rejected suggestions.
May this person see the information in question?
Is this person assigned to review this specific item?
May this person authorise the proposed change to it?
Is this person delegated for it, with current training?
Investigator delegation governs activities at site; sponsor and organisational activities follow the organisation’s own roles. A proposal is routed on whichever applies.
Audit trail · entry 48213 · proposal not acceptedIllustrativeThe AQ Platform and the study record it holds are hosted in Microsoft Azure UK regions. AQ meets the NHS Data Security and Protection Toolkit standard (Standards Met, 2026). Where AI processing runs is stated separately, in Hosting and data.

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✓ Written for first-in-human & Phase 1 sites
✓ Inspection-ready checklists & templates
✓ Aligned to MHRA, FDA & EU Annex 11