Work back from each data lock point: what is owed, where and by when; the tabulations and exposure reconciled to source; the pack held for the named QPPV or physician who signs.
A lock point is set, and case, exposure and register extracts are pulled from supported safety and commercial sources.
02
A calendar entry falls due, and each region clock is computed back from its own lock point, not from a shared date.
Reason
03
A reference dates list is republished, and scope is asked again as a question, with the effectivity lag modelled.
04
An interval closes, and tabulations reconcile to the cases transmitted and acknowledged, not to the database alone.
05
Exposure arrives from commercial, and interval and cumulative stay two figures, in the units each region sent.
Decide
06
An action is taken in another country, and it joins the actions, marketing-status and study sections from a register.
07
Risk-minimisation evidence falls due, drawn from distribution and programme records rather than the safety database.
Out
08
A pack is retained as a dated version, beside the reports it must agree with and the ageing view of what is owed.
09
A write action runs only inside the approval boundaries agreed during implementation.
→Product statement
The agent assembles the pack and keeps the calendar; a named QPPV or safety physician assesses the interval and signs it.
Example workflow
One interval, lock point to signature
AgentHuman
1Lock point reachedCase data, exposure extracts, action registers and regional calendars
2Pack assembledTabulations, exposure, actions and study status, each with its named source
3Sections draftedTabulations, exposure, registers, open items and confidence
4Controls appliedReconciliation tests, calendar checks, cross-report consistency and confidence threshold
No human action required
Stages 1 to 4 run unaided, and nothing is concluded at any of them — the agent is assembling evidence, and the physician lane opens at the confidence gate.
5DecisionBranches at the confidence threshold
High confidence
Goes to the safety physician.
Low confidence
Adds a reconciliation read first.
Physician review
The pack is held with its sources, its open items and the confidence.
Approve · Amend · Send for reconciliation
Approved — released to the signer▼
6Reporting record updatedOnly where write access and approval policy allow it
7Outcome evaluatedAmendment distance, open-item outcomes, reconciliation findings and post-submission corrections
Amendments
Every physician amendment is counted in the evaluation.
What should not run autonomously
Human approval stays in control
Outside the boundary — human approval required8 items
Concluding that no new safety concern arose.
Writing the scientific benefit-risk evaluation.
Signing the report, or naming who signs it.
Assessing causality on an individual case.
Automation boundaryAgent acts unaided
✓Assemble the tabulations and exposure against their sources.
✓Compute the calendar for each region from its own lock point.
✓Build the actions and study sections from the registers on file.
✓Name what is missing, what changed and what is open, and hold the pack.
Writes run only inside the boundaries agreed at implementation, never ahead of a signature.
Deciding that a signal is closed, or that none arose.
Carrying a conclusion forward from the previous interval.
Answering a request for supplementary information.
Changes to calendar, scope or approval rules.
Example output
One report section, annotated
Everything the agent assembles is attached to the source it was drawn from.
Aggregate report output · single sectionIllustrative example
Product
Assembled section
Time to submission
Source of record
Confidence
Signer of record
Centrally authorised
Interval case tabulation, reconciled to what was transmitted
38 days
Safety database extract
88%
QPPV determines who signs
As receivedTaken from the safety database and the transmission log — nothing on this side is written by the agent.
A portfolio-level on-time submission rate is published by no regulator we found, and a clean internal one can still hide the cohorts carrying the amendments. Nestack reports the amendment rate by cohort, not only in total.
Slice performance — reported separately, not only in aggregateIllustrative example
Slice
Failure rate
Lift
Lift vs. threshold
Status
Products newly swept into scope
9.3%
3.6×
Review
Reports with a moved lock point
6.8%
2.7×
Review
Development safety reports
4.6%
1.8×
Watch
Established annual reports
2.4%
0.9×
Normal
Bar: amendment-rate lift vs. established-report baseline · scale 0–4.0× · tick marks the 2.0× review threshold2 of 4 slices over threshold
Evidence-linked improvement
No interval closes without a new test
A cycle closes when the missed report is a regression case. That suite is what the next interval assembled is measured against.
Improvement cycle · five stagesSwitchback — the path turns at Improve and returns at Learn
01Detect
Amendment rate rises for one report type.
02Diagnose
The lock point that moved after a migration and took the upstream extracts with it is read back until the cause narrows to one.
03Improve
The fix carries a number, and the reports that forced it travel with it.
04Verify
Nothing goes out until every touched interval case has passed again.
05Learn
It is kept permanently, and the calendar rules are amended alongside it.
Learn → DetectThe return edge. The next interval runs against a suite one case longer.
Typical build scope
Twelve workstreams across six weeks
The build scope read against the delivery timeline. Week structure follows the six-week plan — discovery, sources, assembly workflow, evaluation, integration, then production validation and handover.
WorkstreamWeek 1Week 2Week 3Week 4Week 5Week 6
01Reporting workflow discovery and boundary mapping.
02Safety and commercial source assessment.
03Calendar, scope and reconciliation rule mapping.
04Extract ingestion and normalisation.
05Pack assembly and source binding.
06Confidence scoring and exception routing.
07Physician review workflow.
08Safety and regulatory system integration.
09Calendar and tabulation cases.
10Guardrails and assessment controls.
11Interval-trail instrumentation.
12Deployment, documentation 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 product, one intervalProductionProduction safety systemsAdvancedMultiple products / regions
Introduced at Pilot
Assembly and reconciliation✓✓✓
Held for the named signer✓✓✓
Tabulation-accuracy baseline✓✓✓
Introduced at Production
Reporting by product—✓✓
Exception workflow in your systems—✓✓
Approved write-back—✓✓
Safety-database integration—✓✓
Introduced at Advanced
Multi-substance portfolios——✓
Multi-stage signer routing——✓
High product count——✓
Multi-region calendar controls——✓
Build priceFrom $5,000From $8,000Custom quote
Final build priceConfirmed after discovery based on integrations, workflow complexity, transaction volume, approval 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
01Your product list and reporting obligations→Calendar, scope and reconciliation rule mappingWeek 1
02Representative prior periodic reports→Extract ingestion, reconciliation and the assembly baselineWeek 2
03Your registers of actions, studies and signals→Register mapping and automation-boundary definitionWeek 1
04Access to relevant APIs, feeds or exports→Safety and commercial source assessment, then integration setupWeek 2
05Reports you would not want inspected→Interval cases and the evaluation suiteWeek 4
06What no periodic report may conclude→Confidence scoring, exception routing, guardrails and assessment controlsWeek 3
07Named QPPV or safety physician to assess→Physician review workflow, then pilot and production validationWeeks 5–6
Nothing else is requiredDeployment, documentation and Agent Care handover are ours.
Delivery timeline
Four phases across six weeks
Weeks of real work set every band width on this chart, which is the reason the fifth carries two.
PhaseW1W2W3W4W5W6
DiscoveryW1
BuildW2 – W3
EvaluateW4 – W5
Pilot & LaunchW5 – W6
Week focusW1Reporting workflow discovery, rule mapping and the automation boundaryW2Source integration and the reconciliation baselineW3Assembly workflow, confidence logic and review controlsW4Evaluation suite, calendar checks and failure-mode testingW5Safety-system integration, a pilot interval and targeted correctionsW6One reporting interval run under the QPPV, then Agent Care handover
Reading the bandA bar spans only the weeks its own work is named in. The week 5 overlap is real, not padding.
At the end of W6The final checks clear on live intervals and monitoring moves to Agent Care.
DurationSix-week plan shown · typical delivery 4–6 weeks depending on scope confirmed in discovery.
Next step · Biotechnology AI agent
Build the report pack before the next lock point falls.
Show us your products, your lock points and the qualified person named under Directive 2001/83/EC Articles 8(3)(ia) and 104(3)(a). What does the agent hand that person at the end of an interval — the pack, the reconciliations, the open items and what was shown, with the benefit-risk section left empty, because that sentence belongs to the signer.
