Biotechnology AI agent · Aggregate reports
Aggregate Safety Report Assembly AI Agent
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.
- Typical delivery
- 4–6 weeks
- Deployment
- Your stack
- QPPV signs
- Calendar-driven
- After launch
- Agent Care
What this agent does
Assembles the pack, never the conclusion
In
- 01
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
- 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.
Goes to the safety physician.
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 required
8 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 boundary
Agent 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 section
Illustrative example- Product
- Centrally authorised
- Assembled section
- Interval case tabulation, reconciled to what was transmitted
- Time to submission
- 38 days
- Source of record
- Safety database extract
- Confidence
- 88%
- Signer of record
- QPPV determines who signs
As received
Taken from the safety database and the transmission log — nothing on this side is written by the agent.
Source facts used
- Transmitted ICSR log
- Exposure extract, dated
- Signal register entry
Why this is open
Cases sit in the database that the receiving system never acknowledged.
What the score decides
Below the configured threshold the section picks up a reconciliation read before the physician sees it.
Action
ApproveAmendSend for reconciliationValue
Where AI adds value
The same four claims, placed at the point in the workflow where each one applies.
Where the value lands
Value 01 – 04
Every product
From the reporting obligation
Read the interval against its sources
Numbers in the pack are set beside the system each came from; what they mean stays with the signer.
The conclusion stays unwritten
Article 107b of Directive 2001/83/EC requires a scientific evaluation of the benefit-risk balance. The agent pre-drafts no such sentence, in any form.
Case, signal, programme
Case processing works a case, signal detection works a hypothesis, this page works a calendar — and none of the three reaches a conclusion.
Build an evidence trail
The interval, the data-lock point behind it and the physician who signed stay on the report.
Integrations
Typical integrations
Five system groups connect to the same agent. Which of them are in scope is decided in discovery.
Safety database
- Oracle Argus
- ArisGlobal
- Veeva Vault Safety
Regulatory information
- Veeva Vault RIM
- EU reference dates list
Exposure and commercial
- ERP shipment data
- Prescription and sales extracts
Agent
Aggregate report assembly
- Reads the sources
- Assembles the pack
- Holds for the signer
Registers and documents
- Signal and RMP registers
- PSMF and document systems
Observability & evaluation
- OpenTelemetry
- Langfuse
- Supported monitoring/evaluation sources
Integration availability depends on the client's existing systems and API access.
Agent controls
Six layers between the model and the report
Six bands, each one inside the last. Anything that survives them is listed in the map below.
L6 · Outermost — last line of defence
Inward → L1 · closest to the model
- L1 – L2
- Test whether the pack may stand
- L3
- Puts the release in the hands of the signer
- L4 – L5
- Keep the interval and the lock point behind it
- L6
- Holds the report at unassessed when signals degrade
How Nestack evaluates it
Evaluate the assembly workflow — not only the finished report.
Coverage runs the whole depth of the workflow, and every layer is cut by slice.
Surface — the pack the signer reads
- E1Final-output evaluationDid every number trace to the system it came from?
- E2Step-level evaluationDid the agent use the right lock point, interval and product configuration?
- E3Tool evaluationDid it read and write the correct product and the correct interval?
- E4Confidence calibrationDo low-confidence sections actually attract more physician amendments?
- E5Slice evaluationHow does performance change across specific report types?
- E6Business outcomeHow many sections were amended, or corrected after submission?
Floor — the outcome the holder answers for
Failure modes
Where each failure originates in the agent
Seven failure modes, each set at the stage where it first arises.
Agent lifecycle
Direction of processing →
01 · Retrieval
1 mode
- EM-03
Scope read as current
The list published today does not bind today.
Stage gathers
Cases, exposure, registers and regional calendars
02 · Reasoning
2 modes
- EM-04
Denominators totalled
Patient-days and packs sold become one figure.
- EM-06
Effectivity lag ignored
A product is flagged in scope before it is.
Stage proposes
Tabulations, exposure, registers and confidence
03 · Tool / write
2 modes
- EM-02
Waiver applied family-wide
A waiver for one application stops other filings.
- EM-05
Assembled per programme
Two dosage forms produce two exposure figures.
Stage writes
Only where write access and approval policy allow it
04 · Output
1 mode
- EM-01
Reconciled to the database
Not to what was transmitted and acknowledged.
Stage returns
The pack the named signer assesses and submits
05 · Change / Version
1 mode
- EM-07
Silent template carry-forward
A template reinstates the previous conclusion.
Stage tracks
Model, prompt, calendar rules and product config
- Sev-1 · a conclusion reaches a signature
- Sev-2 · a wrong number reaches the report
- Sev-3 · source degrades, section to review
Affected slices
A clean portfolio total can hide one report type
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 aggregate
Illustrative 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 threshold
2 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 stages
Switchback — the path turns at Improve and returns at Learn
- 01
Detect
Amendment rate rises for one report type.
- 02
Diagnose
The lock point that moved after a migration and took the upstream extracts with it is read back until the cause narrows to one.
- 03
Improve
The fix carries a number, and the reports that forced it travel with it.
- 04
Verify
Nothing goes out until every touched interval case has passed again.
- 05
Learn
It is kept permanently, and the calendar rules are amended alongside it.
Learn → Detect
The 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.
Workstream
Week 1Week 2Week 3Week 4Week 5Week 6
- 01Reporting workflow discovery and boundary mapping.Week 1
- 02Safety and commercial source assessment.Week 1, Week 2
- 03Calendar, scope and reconciliation rule mapping.Week 1, Week 2
- 04Extract ingestion and normalisation.Week 2
- 05Pack assembly and source binding.Week 2, Week 3
- 06Confidence scoring and exception routing.Week 3
- 07Physician review workflow.Week 3, Week 4
- 08Safety and regulatory system integration.Week 5
- 09Calendar and tabulation cases.Week 4, Week 5
- 10Guardrails and assessment controls.Week 4
- 11Interval-trail instrumentation.Week 5, Week 6
- 12Deployment, documentation and Agent Care handover.Week 6
12 workstreams · 6 weeks · bar shows the weeks a workstream is active — several run in parallel
Final 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 tier | PilotOne product, one interval | ProductionProduction safety systems | AdvancedMultiple 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 price | From $5,000 | From $8,000 | Custom quote |
- Final build price
- Confirmed after discovery based on integrations, workflow complexity, transaction volume, approval controls and deployment requirements.
- Separate from build
- Build 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 bring
We build with it
01Your product list and reporting obligations
→Calendar, scope and reconciliation rule mapping
Week 102Representative prior periodic reports
→Extract ingestion, reconciliation and the assembly baseline
Week 203Your registers of actions, studies and signals
→Register mapping and automation-boundary definition
Week 104Access to relevant APIs, feeds or exports
→Safety and commercial source assessment, then integration setup
Week 205Reports you would not want inspected
→Interval cases and the evaluation suite
Week 406What no periodic report may conclude
→Confidence scoring, exception routing, guardrails and assessment controls
Week 307Named QPPV or safety physician to assess
→Physician review workflow, then pilot and production validation
Weeks 5–6
Nothing else is required
Deployment, 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.
Phase
W1
W2
W3
W4
W5
W6
- DiscoveryW1
- BuildW2 – W3
- EvaluateW4 – W5
- Pilot & LaunchW5 – W6
Week focus
W1Reporting workflow discovery, rule mapping and the automation boundary
W2Source integration and the reconciliation baseline
W3Assembly workflow, confidence logic and review controls
W4Evaluation suite, calendar checks and failure-mode testing
W5Safety-system integration, a pilot interval and targeted corrections
W6One reporting interval run under the QPPV, then Agent Care handover
- Reading the band
- A bar spans only the weeks its own work is named in. The week 5 overlap is real, not padding.
- At the end of W6
- The final checks clear on live intervals and monitoring moves to Agent Care.
- Duration
- Six-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.
- Typical delivery
- 4–6 weeks
- Deployment
- Your safety systems
- QPPV signs
- Calendar-driven
- After launch
- Agent Care available
Nestack Agents · Aggregate safety report assembly
AGT-BT-16 · Agent Care available after launch