Connected Intelligence

Connected AI for clinical trial delivery and oversight.

AQ Platform combines document intelligence, study assessment and drafting assistance to reduce administrative effort and support informed decisions across studies and sites.

9Modules read together
1Study record
0Changes without a reviewer
CTMS
eTMF
eISF
Pharmacy
QMS
CAPA
Digital DoA
eSource
Labs
Reading records · 3 modulesThe same protocol deviation type recorded at three of five sites in eight weeks Quality lead
The contribution

Assess the wider impact of study changes.

Revised procedures, protocol amendments and storage excursions affect related activities. AQ identifies those connections and assembles the information needed to plan a coordinated response.

1 · TriggerFridge 2 outside range
2 · Records readPharmacy · CAPA
3 · ProposalCorrective action with stock attached
4 · DecisionTrial pharmacist
Example 02 · AQ Pharmacy to AQ CAPA

A temperature excursion is recorded.

01A reading outside range enters AQ Pharmacy from the monitoring record for that storage location.
02AQ identifies the consignments held there and the studies they are allocated to.
03It proposes a corrective action with the affected stock attached. Whether it blocks a phase change is a study configuration.
The decision stays withTrial pharmacistDecides whether to hold the stock and raise the action Awaiting review
Fridge 2 outside rangeIllustrative
Fridge 2 · St. Adeline’s · last 24 h11.4 °C · excursion
8 °C2 °C
C-0912Allocated · BREEZE-2
C-0917Allocated · HARBOUR-1
Corrective actionProposed
Affected stock attached · 2 consignments · 2 studies
Hold the stock · raise the actionTrial pharmacist

Each draws on records held in several modules. A tool scoped to one of them produces one part of the answer.

In use

Understand what needs attention across sites.

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 openIllustrative
4Open items
2Awaiting review
2Reviewed
9Modules read
Items by site
Riverside Trust3
St. Adeline’s2
Northgate1
Harbour View0
Ellesmere1
Raised in the last 8 weeks
W1W8
Act nowThis monthReview
3 OctThree sites

The same protocol deviation type has been recorded at three of five sites in eight weeks

Records considered
Deviation recordsCorrective actionsSOP-022

Individually each was closed locally. Together they suggest the procedure rather than the site is the cause.

—Quality leadNot yet assigned to a personAwaiting review
7 OctRiverside Trust

Two required documents are outstanding against the Start-up milestone at Riverside Trust

Records considered
Expected-document listCurrent versionsMilestone plan

The milestone cannot be marked complete, and the study is scheduled to move to Conduct this month.

PNSite file ownerPriya NairReviewed
1 OctAll sites

SOP-014 version 3 is outstanding for 17 of 48 assigned staff

Records considered
Version historyLearning assignmentsDelegated tasks

Eleven of the seventeen hold delegated tasks that reference it.

HMQuality leadHannah MossReviewed
9 OctSt. Adeline’s

A storage excursion at St. Adeline’s affects consignments allocated to two studies

Records considered
Monitoring recordPharmacy inventoryStudy allocation

The consignments are held pending assessment.

—Trial pharmacistNot yet assigned to a personAwaiting review

Illustrative, fictional data.

Why the first item matters · deviations by site, last 8 weeksIllustrative
W1W2W3W4W5W6W7W8Local view Riverside TrustClosed locallySt. Adeline’sClosed locallyNorthgateClosed locallyHarbour ViewNoneEllesmereNone
SOP-022 · consent processReferenced by all four deviations
Read togetherThe procedure, not the site, is suggested as the causeQuality lead

No single site’s record contains the pattern. It appears only when the deviations, the corrective actions and the procedure are read together.

Deviation recordsCorrective actionsShared procedure
Nine capabilities

AI assistance across clinical trial workflows.

Document classification, readiness assessment, drafting and evidence retrieval draw on information already held within AQ Platform, reducing the preparation required for routine study activities.

Reads the record
Produces proposals
Answers and assembles
Document intelligence · BREEZE-2Illustrative

Document intelligence.

AQ 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.

Classification is proposed rather than searched for.
Reyes_CV_signed_2026.pdfArrived 09:14 · 2 pages · uploaded by R. OkaforNew
Proposed placement
ClassificationCurriculum vitae
Expected entryeISF 02.03 · Investigator CV
Versionv2 · supersedes 14 Mar 2025
SignatureDated · applied
ConfidenceHigh · 3 fields read
Site file ownerAssigned reviewerConfirmCorrect

Where a check runs on a configured rule rather than a model, AQ describes it as automated. Illustrative, fictional data.

How to evaluate

What to assess in clinical trial AI.

Evaluate the information each feature uses, the task its output supports, the authority required for approval and the evidence retained for subsequent examination.

03

Who can approve it?

A permission-based assistant
Access permissionInherits what the user may see
Review responsibility
Approval authority
Study delegation and training
AQ Platform
Access permissionMay see it
Review responsibilityAssigned to review it
Approval authorityMay authorise it
Study delegation and trainingDelegated · training current
All four are held in the same record, so a proposal can be routed against the delegation and training behind the task, not access alone
Question 03 · most often answered only in partInheriting a user’s access permissions establishes what they may see. It does not establish the rest. May see itDelegated to do it · not establishedTraining current · not established
Quality risk detection

Recognise recurring quality issues across sites.

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 sitesIllustrative
A deviation type recurring across sitesEach closed locally · same procedure referenced · 8 weeks
Riverside2Closed locally
St. Adeline’s1Closed locally
Northgate1Closed locally
Harbour View0None
Ellesmere0None
Supporting records
Deviation records · 3 sitesCorrective actions · 4SOP-022 · consent process
The reviewer assesses: whether the procedure is the cause, with the site records supporting the assessment.
—Quality leadNot yet assigned to a personAwaiting assessment

AQ raises the flag and supplies the records behind it. The assessment and its reasoning are the quality lead’s.

Documentation gaps

Identify documentation gaps against study requirements.

Expected documents, versions and signatures are checked alongside relevant training and delegation requirements, highlighting information that is missing, outdated or incomplete.

Expected documents

01
eTMF · eISF

What the file should hold at this point in the study.

Expected9Filed7

Versions and signatures

02
eTMF · eISF

Whether the filed version is current and signed.

Current7Signed6

Training

03
QMS · Digital DoA

Whether required training is assigned and complete.

Assigned48Complete31

Delegation

04
Digital DoA

Whether the person is delegated and the delegation is current.

Delegated11Current10
One gap, read against two records · BREEZE-2 · Riverside TrustIllustrative
Site file entry
eISF 02.03 · Investigator CV · Dr Reyes
Filed versionv1 · signed 14 Mar 2024
Expiry14 March 2026
Current versionNone filed
As a filing matterOne outstanding document
Delegation record
Delegation log · Dr Reyes
ActivityTake informed consent
StatusLive · performed this week
Effective from2 February 2026
RequirementCurrent CV · outstanding
Raised against the delegation, not the folder: an outstanding requirement behind an activity still being performed. Principal InvestigatorAwaiting review
DR Dr Reyes · Riverside TrustHolds a live delegation to take informed consent. Her CV in the site file expired on 14 March; no current version is filed. One gap · two readings
Read as a filing matter
One outstanding document

The expired CV is a missing item in eISF 02.03, sitting in a queue of documents to chase.

eISF 02.03Expired 14 MarLow urgency
Read against the live delegation
An outstanding requirement behind an activity still being performed

Consent is being taken this week under a delegation whose supporting requirement has lapsed.

Delegation · livePerformed this weekRaised to the PI
This is why AQ raises it against the delegation rather than against the folder.Principal Investigator
AQ Assist · conversational interface

Study answers with supporting source records.

AQ Assist retrieves and summarises accessible study information, providing references and identifying missing information so the response can be examined in context.

Live demonstration · four questions
AQ Assist
AI-enabled help for AQ Trials. Live responses in chat.
Guide
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Recent
Riverside · pre-visit itemseISF · Today
IMP dispensing · delegationPharmacy · Today
Corrective actions · SOP-014QMS · Today
Recruitment · screen failureStudy · Today
HMHannah MossQuality lead
What is outstanding at Riverside Trust before the monitoring visit on 21 January?
eISF · Today, 10:52

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.

1Investigator CV · Dr Reyes · current versionOverdue
2SOP-014 v3 training · 4 staffOverdue
3Delegation log · 2 signaturesDue 9 Jan
Records citedCheckable
Investigator CVDr Reyes · eISF 02.03Open record
Learning assignmentsSOP-014 v3Open record
Delegation logRiverside TrustOpen record
Based on 4 records · the record does not hold a training plan for Ellesmere, which is not included.
Follow-up questions
Which of the eight are gated?Draft the pre-visit summary
Ask about BREEZE-2…
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Today’s usage
Organisation4 used · 46 left
You1 used · 49 left
Every answer cites its recordsAnswers inside the user’s permissions, delegation and blindingSays what is missing rather than guessing

Illustrative, fictional data. Interface shown as in AQ Platform.

Review and control

Defined responsibilities and traceable decisions.

AI suggestions follow the applicable review and approval process, with supporting sources, reviewer details and decisions retained, including rejected suggestions.

Access permission

01

May this person see the information in question?

Review responsibility

02

Is this person assigned to review this specific item?

Approval authority

03

May this person authorise the proposed change to it?

Study delegation

04

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.

The hand-off, step by stepAQReviewer
AQ reads the record across modulesFlags what is outstanding, expiring or inconsistent, with the records behind each flag.
The reviewer decides what to act onAnd in what order. Nothing is queued for action by AQ.
AQ proposes and draftsA classification, a pre-visit summary, a reply to a monitoring query.
The reviewer confirms, edits and sendsNothing leaves the record unreviewed.
AQ flags patterns across sites and studiesWith the deviations, actions and procedures that support them.
The reviewer assesses whether it is a findingAnd records the reasoning with the decision.
Audit trail · entry 48213 · proposal not acceptedIllustrative
ProposalClassify Reyes_CV_signed_2026.pdf as eISF 02.03 Investigator CV, v2
Model · versionDocument intelligence · model ci-doc · v2.4.1
Records drawn oneISF 02.03 expected-document entry · version history · signature requirement
DecisionRejected
ReviewerPriya Nair · Site file owner
Recorded reasonDocument is a GCP certificate scanned with the CV cover sheet. Refiled to 02.05 manually.
Timestamp7 Oct 2026 · 09:21:48 UTC
Proposal and decision retained together, including where the proposal was not accepted.
Five guardrailsICH-GCP E6(R3)ALCOA+21 CFR Part 11NHS DSPT 2026
01Recommend, not decideA person with authority confirms every change.
02Audit everythingProposal, decision, model and records retained.
03Validated for intended useScoped and measured against known-correct examples.
04Rules remain the controlWhere a rule governs a gate, the rule governs it.
05Data stays under controlCustomer data is never used to train a model.
Guide · AI in GxP systemsIs it safe to use AI in GxP clinical trial systems?Validation, audit trail and the four questions that govern approval, explained for QA and R&D leads. Read the AI governance guide
Questions

Questions about Connected Intelligence.

The 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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