Track sites and subjects against the protocol schedule, find deviations and discrepancies, draft queries and keep the trial master file picture visible — for your medical monitor, CRA and investigator to act on.
Take the protocol, its visit schedule and the plans that say what counts as an important deviation.
02
Read the study systems as copies — subject status, visits, forms, queries, monitoring records and the TMF index.
Reason
03
Compare each subject's visits, windows and required forms against the schedule the protocol sets.
04
Look for deviations, missing pages and values that disagree between forms or between two systems.
05
Draft queries in the site's own wording, and assemble the site picture a CRA takes into a visit.
Decide
06
Send a subject-safety signal or a possible serious breach to a named person at once, not to a queue.
07
Hold anything whose record copy, consent version or blinding status cannot be confirmed.
Out
08
Present the deviation list, the drafted queries, the TMF gaps and the visit pack with the record behind each.
09
Retain the reads, the drafts, the reviewer edits and the plan version the run was made under.
→Product statement
The agent tracks, compares, drafts and routes inside the approval boundaries agreed during implementation. Eligibility, enrolment, randomisation, unblinding, clinical decisions and query closure stay with the investigator, the medical monitor and the sponsor's named roles.
Example workflow
One site review, end to end
AgentHuman
1Protocol and plans readThe protocol, its visit schedule, the monitoring plan and what the sponsor pre-specified as an important deviation
2Study data copied inSubject status, visits, forms, queries, monitoring records and the TMF index, read as copies with each read logged
3Schedule comparedEach subject's visits, windows, required forms and consent version set against what the protocol states
4Findings and drafts preparedDeviations, discrepancies and TMF gaps listed, queries drafted and the site-visit pack assembled
No human action required
Stages 1 to 4 run without a person in the loop — the medical monitor is not asked to read anything until the comparison and the record checks are done. A subject-safety signal leaves for a named person the moment it is seen.
5DecisionSplits on the record check and the confidence gate
Findings hold up
Goes to the monitor as a drafted review.
A record will not confirm
Held with the unconfirmed findings marked.
Medical monitor, CRA and investigator
Read the deviation list and the drafted queries against what could not be confirmed on a record copy.
Approve · Amend · Escalate
Approved — handed back▼
6Pack filed to the study systemsWritten as drafts only where access and policy allow; no query is answered, and none is closed
7Outcome evaluatedDeviations missed, queries the monitor rewrote, findings dropped as false and what the CRA found on site
Amendments
Findings the monitor rewrites or drops are counted in the evaluation.
What should not run autonomously
Human approval stays in control
Outside the boundary — human approval required8 items
Assessing eligibility or enrolling a subject.
Randomising, withdrawing or discontinuing a subject.
Any clinical decision or instruction about a subject.
Unblinding, or releasing treatment-revealing data.
Automation boundaryAgent acts unaided
✓Compare visits and forms to the protocol schedule.
✓List candidate deviations, discrepancies and TMF gaps.
✓Draft queries and assemble the site-visit pack from record copies.
✓Check consent version and blinding status, and hold what will not confirm.
Write actions run only inside the approval boundaries agreed during implementation. Closing a query is not one of them.
Altering source data or a source document.
Deciding that a deviation is not reportable.
Answering, signing or closing a query.
Changing the protocol, the plans or the thresholds.
Example output
One flagged visit, annotated
Everything the agent flags is attached to the record copy and the protocol rule it came from.
Deviation review · single subject visitIllustrative example
Site
Subject
Visit
Proposed
Confidence
Reportability
Investigator site, blinded view
Randomised, arm not shown
V4, ±3 days
Visit outside its window
91%
Left for the sponsor
As receivedThe visit and the schedule as the study systems hold them, read as a copy — nothing on this side is edited.
Evidence usedProtocol visit scheduleVisit date on the copyConsent version in force
Why it is flaggedThe visit falls outside the window the protocol sets, and the plan calls that important.
ActionApproveAmendEscalate
What the score decidesBelow the configured threshold the finding is held for the monitor instead of the pack.
Value
Where AI adds value
The same four claims, placed at the point in the workflow where each one applies.
Where the value landsValue 01 – 04
Every subject visit and formFrom your study systems
03Comparison & drafting
Hold the study to its own schedule
Use the visit schedule, the windows, the monitoring plan and what the sponsor pre-specified as important.
01Approved path
Cut the reading before the judgement
The deviation list, the discrepancies and the drafted queries arrive together, so a medical monitor spends the time on the calls only they can make.
02Human review
Send the CRA to the sites that moved
Out-of-window visits, ageing queries, consent-version gaps and missing trial master file records are named per site, so a visit is planned on what changed.
04Build an evidence trail
Retain the copies read, the protocol rule behind each finding, the drafted query, the confidence, who was told of a safety signal and every reviewer edit — on both paths.
Integrations
Typical integrations
Five system groups connect to the same agent. Which of them are in scope is decided in discovery.
EDC & clinical dataMedidata Rave · Veeva CDMS Oracle Clinical One · data APIs
CTMS & site managementVeeva CTMS · Medidata CTMS · site status Visit reports · issue logs
eTMF & documentsVeeva Vault eTMF · Montrium SharePoint · TMF Reference Model index
Agent
Clinical-trial support
Reads study copies Compares to protocol Routes to the monitor
Integration availability depends on the client's existing systems and API access.
Agent controls
Six layers between the model and the study record
Each control wraps the one inside it. A finding clears every layer before it reaches the pack a medical monitor reads.
L6 · Outermost — last line of defenceInward → L1 · closest to the model
L6Rollback / safe modeRestrict automation if evaluations or production signals degrade.Roll back
L5Trail and versionReads, findings, reviewer edits and model, prompt and rule changes are recorded under change control.Record
L4Monitor and PI gateDefine what may be filed as a draft; answering or closing a query waits for the site and the monitor.Gate
L3Safety routingWording on the sponsor's safety and breach lists pages a named person and records when the clock started.Escalate
L2Blinding controlsFields set as treatment-revealing are withheld by role and a read outside it refused; a field nobody set as revealing is not caught here.Withhold
L1Record bindingFindings are checked against the record copy and the protocol rule they name; unbound ones are held.Verify
Model coreFinding proposed — the deviation or discrepancy, the record copy behind it, a drafted query and confidence
L1 – L2Decide if a finding stands and who sees it
L3Routes safety wording to a person, records the clock
L4 – L5Leave the decision to the site, keep the trail
L6Pulls automation back when signals degrade
How Nestack evaluates it
Evaluate the whole review — not only the deviation list at the end.
Coverage runs the whole depth of the workflow, and every layer is cut by slice.
Surface — the review pack the monitor opens
Depth of coverage ▼
E1Final-output evaluationWas the finding real, and the deviation the protocol actually defines?
E2Comparison evaluationWere visits, windows and forms read against the current protocol version?
E3Blinding evaluationDid a treatment-revealing field reach a role that should not see it?
E4Query-draft evaluationDid the query name its record and ask one answerable thing?
E5Slice evaluationHow does performance change across specific site and subject cohorts?
E6Business outcomeHow much of the pack was rewritten, and how many gaps were already filed?
Floor — the study conduct the sponsor has to defend
Failure modes
Where each failure originates in the agent
Seven failure modes plotted against the five stages of the agent lifecycle.
Agent lifecycleDirection of processing →
01 · Intake / retrieval2 modes
TR-01
Compared against a superseded protocol
An amendment moved the window; the old schedule still runs.
TR-02
Consent version not read at the visit
A visit is reviewed against a form the subject never signed.
Stage gathersThe protocol, its schedule and the study systems as copies
02 · Comparison2 modes
TR-03
Deviation left off the list
A visit outside its window reads as compliant and is never raised.
TR-04
Query raised against data that is right
The site is asked to explain a value its own source copy supports.
Stage comparesSubject visits, windows and forms against the schedule
03 · Drafting1 mode
TR-05
Treatment-revealing value in a query
A drafted query quotes a field that shows the arm.
Stage draftsQueries, the deviation list and the site-visit pack
04 · Pack / output1 mode
TR-06
Safety signal handled as a data issue
An event in the data is read as a discrepancy, not a signal.
Stage returnsWhat the monitor, the CRA and the investigator read
05 · Change / Version1 mode
TR-07
Silent rule change moves the findings
A check or threshold changes with no record of who approved it.
Stage tracksAmendments, model, prompt and rule changes
Sev-1 · the study or the blind is put at riskSev-2 · the pack misstates what happenedSev-3 · findings degrade, sites carry the cost
A site three weeks old is not a site three years old
Sites are not equivalent and this number says so. It counts findings the monitor dropped or rewrote before the pack went out, highest where staff have not run the schedule yet or where source is on paper.
Slice performance — reported separately, not only in aggregateIllustrative example
Slice
Failure rate
Lift
Lift vs. threshold
Status
Newly activated sites
5.9%
3.4×
Review
Paper-source and scanned visits
4.1%
2.3×
Review
Subjects under an amended protocol
3.0%
1.7×
Watch
Long-running stable sites
1.3%
0.7×
Normal
Bar: dropped-finding lift vs. stable-site baseline · scale 0–4.0× · tick marks the 2.0× review threshold2 of 4 slices over threshold
Evidence-linked improvement
One dropped finding changes the check that produced it
A finding the monitor threw out is not fixed by throwing it out. The check behind it moves under version control, and the next pack is read against that.
Improvement cycle · five stagesSwitchback — the path turns at Improve and returns at Learn
01Detect
Dropped findings or missed deviations rise at one kind of site.
02Diagnose
Either the rule was wrong or the copy it read was, and both happen.
03Improve
The check or the schedule map is changed under change control, approver named.
04Verify
The affected subjects and sites are compared again from the copies.
05Learn
The dropped finding stays in the test set, with what the monitor wrote instead.
Learn → DetectThe return edge. A change to a check or a threshold in a study system is itself a change — approved, recorded and version-linked before the next comparison runs.
Typical build scope
Twelve workstreams across six weeks
The build scope read against the delivery timeline. Week structure follows the six-week plan — discovery, access and copies, comparison and drafting, evaluation, integration, then production validation and handover.
WorkstreamWeek 1Week 2Week 3Week 4Week 5Week 6
01Workflow discovery and boundary definition.
02Study-system access and blinded-role design.
03Protocol, schedule and deviation-plan mapping.
04Record copying, read logging and source rules.
05Visit, window and required-form comparison.
06Deviation and discrepancy detection logic.
07Query drafting in the site's own wording.
08Trial master file gap and index checks.
09Safety-signal and serious-breach escalation routing.
10Monitor, CRA and investigator review workflow.
11Evaluation suite and regression subjects.
12Integration, deployment and Agent Care handover.
12 workstreams · 6 weeks · bar shows the weeks a workstream is active — several run in parallelFinal scope and sequence confirmed in discovery
Engagement tiers
What each tier includes
Rows are the capabilities named in each tier's scope. Higher tiers include everything below them.
Capability✓ in scope · — not at this tierPilotOne study, one site groupProductionProduction integrationAdvancedSeveral studies / programmes
Introduced at Pilot
Schedule comparison and deviation findings✓✓✓
Trial master file gap list✓✓✓
Blinded-role access and source copies✓✓✓
Consent-version and status checks✓✓✓
Safety and serious-breach routing✓✓✓
Query drafting and review pack✓✓✓
Baseline evaluation✓✓✓
Introduced at Production
Study-system and eTMF integration—✓✓
Observability and evaluation—✓✓
Introduced at Advanced
Several studies, sites and languages——✓
Multi-programme and enterprise controls——✓
Build priceFrom $5,000From $8,000Custom quote
Final build priceConfirmed after discovery based on the studies and systems in scope, site and country coverage, subject volume, monitoring and review controls and deployment requirements.
Separate from buildBuild pricing is separate from recurring Agent Care, which covers managed monitoring, evaluations, incidents and verified improvements after launch.
What we need from you
What you bring, and what we build with it
Each input maps to a piece of build scope and a week in the delivery timeline.
You bringWe build with it
01The protocol, its visit schedule and the deviation plan→Protocol, schedule and deviation-plan mappingWeek 1
02Who may see unblinded data, and who must not→Study-system access and blinded-role designWeek 1
03Read access to the EDC, CTMS and eTMF you run→Record copying, read logging and source rulesWeek 2
04A monitoring visit report your CRA has already written→Visit, window and required-form comparisonWeek 3
05Queries your data managers wrote — the good and the wasted→Query drafting in the site's own wordingWeek 3
06Findings that went wrong — a missed deviation, a bad query→Evaluation suite, regression subjects and failure-mode testingWeek 4
07Named medical monitor, CRAs and investigator contacts→Review workflow, then pilot sites and production validationWeeks 5–6
Nothing else is requiredDeployment, documentation and Agent Care handover are ours.
Delivery timeline
Four phases across six weeks
Phases are drawn over the weeks they actually occupy. Week 5 puts the first drafted findings in front of a monitor while the cohort slices are still running.
PhaseW1W2W3W4W5W6
DiscoveryW1
BuildW2 – W3
EvaluateW4 – W5
Pilot & LaunchW5 – W6
Week focusW1Protocol, schedule, deviation plan and the blinded-role mapW2Study-system access, record copies and read loggingW3Visit and window comparison, deviation and discrepancy logicW4Query drafting, safety-routing tests and site cohort slicesW5Study-system integration, first monitor-reviewed packs and editsW6Production validation, live sites with your monitor and Agent Care handover
Reading the bandA bar covers the weeks its work is named in, and nothing either side. Roles and copies are settled in week 1; a study system read under the wrong role cannot be unread.
At the end of W6The monitor and the CRA decide whether the packs saved them a day. Agent Care picks up the checks, the role map and the drift in both.
DurationSix-week plan shown · typical delivery 4–6 weeks depending on scope confirmed in discovery.
Next step · Biotechnology AI agent
Build a trial-support agent around the study you are already running.
Show us one protocol, the systems your study data sits in and how a deviation reaches your medical monitor today. We do not read a study system until your roles are mapped onto its copies. That map is week one, and it is the part clients most often find they do not have.
