Track each protocol, amendment and semiannual review against the interval it is measured by, and put the calendar, the findings and their correction dates in front of the committee that signs.
A protocol is approved, and the agent runs its expiry against the 9 CFR 2.31(d)(5) floor and your own stated interval.
02
A review falls due, and the agent counts the programme review and the facility inspection as two six-month clocks.
Reason
03
An amendment is filed, and the agent holds the protocol at its current scope until the committee records a decision.
04
A finding is recorded, and the agent shows the plan-and-schedule date the committee wrote against today.
05
A correction date passes, and the agent starts the 15-business-day notice and names every federal sponsor on it.
Decide
06
A person joins a protocol, and the agent tracks training and occupational-health enrolment as separate states.
07
A fiscal year closes, and the agent derives both 1 December reports from one record and shows why the counts differ.
Out
08
A protocol lapses, and its animals, its findings and the assurance it sat under are retained against the record.
09
Execute write actions only inside the approval boundaries agreed during implementation.
→Product statement
The agent assembles the record and runs the clocks; a majority of the committee approves, and the institutional official signs the assurance and the annual report.
Example workflow
One protocol, approval to expiry
AgentHuman
1Protocol receivedProtocol system, amendment form, veterinary record or facility register
2Record assembledSpecies, procedures, personnel, training and facility, each with its named source
3Calendar draftedExpiry dates, review windows, open findings and confidence
4Controls appliedInterval checks, amendment and training currency, finding dates and confidence threshold
No human action required
Stages 1 to 4 run unaided, and nothing is decided or closed at any of them — the agent is assembling, and the committee's lane opens at the confidence gate.
5DecisionBranches at the confidence threshold
High confidence
Goes to the IACUC chair to read.
Low confidence
Adds an attending veterinarian read first.
Committee review
The record is held with its sources, its open findings and the confidence.
Approve · Edit · Send to the attending vet
Approved — released to the committee▼
6Protocol registers updatedOnly where write access and approval policy allow it
7Outcome evaluatedRecord completeness, finding-date outcomes, review turnaround and post-report corrections
Edits
Every committee edit is counted, and so is every correction made after the report was signed.
What should not run autonomously
Human approval stays in control
Outside the boundary — human approval required8 items
Writing the alternatives narrative under 9 CFR 2.31(d)(1)(ii).
Running the alternatives search the investigator must consider.
Determining that a procedure causes no more than slight pain.
Assigning the USDA pain and distress column for a protocol.
Automation boundaryAgent acts unaided
✓Run the protocol, amendment, review and training clocks.
✓Assemble the evidence behind both 1 December annual reports.
✓Hold each finding open against the date the committee wrote.
✓Flag a narrative that is missing, undated or copied, and hold the record.
Any write happens inside the boundaries agreed at implementation, never ahead of a committee vote.
Deciding a protocol, an amendment or a suspension.
Closing a finding, or recording it as corrected.
Signing the assurance, the annual report or a noncompliance report.
Changes to interval, escalation or reporting rules.
Example output
One protocol record, annotated
The record is what the committee reads before it votes, and what an inspector reads afterwards.
Protocol-record output · single protocolIllustrative example
Protocol
Flag raised
Review due
Source of record
Confidence
Attribution
Three-year rodent study
The alternatives narrative is undated and repeats an unrelated protocol word for word
Complete review
Prior protocol file
91%
Investigator and protocol ID
As receivedTaken from the protocol file and the committee minutes — nothing on this side is written by the agent.
Evidence usedNarrative date recordedDatabases the PI listedPrior protocol text
Why this was flaggedWe check that the narrative exists and is the investigator's own — we do not write it, and we never will.
ActionApproveEditSend to the attending vet
What the score decidesBelow the configured threshold the record picks up an attending vet read before the committee.
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 protocolFrom the protocol file
03Assembly
Assemble from the record
Draw on the protocol file, the minutes, the training roster and the facility register — the record, never the deliberation.
01Approved path
The committee decides, not us
The chase, the clocks and the assembly come back; the committee's deliberation time is not the saving.
02Human review
Aim the review at what is late
Protocols near expiry and findings past their correction date surface first; the agent never records one as corrected.
04Build an evidence trail
The protocol, the review it is due and the official who signed stay on the assurance.
Integrations
Typical integrations
Five system groups connect to the same agent. Which of them are in scope is decided in discovery.
Protocol systemsCayuse · Topaz Elements Key Solutions · eSirius
Vivarium & censusTick@Lab · Granite Animal census records
Training & occ healthCITI Program records Occupational health file
Agent
Protocol & programme governance
Reads the record Runs the clocks Holds for the committee
A programme-wide figure can hide one species group
A programme-level calendar-currency figure can look sound while a few species groups and protocol types carry most of the rework behind it. Nestack reports the record-rework rate by slice, not only in total.
Slice performance — reported separately, not only in aggregateIllustrative example
Slice
Failure rate
Lift
Lift vs. threshold
Status
Non-human primate protocols
6.7%
3.6×
Review
Amended field-study protocols
4.7%
2.5×
Review
USDA-covered farm species
3.0%
1.6×
Watch
Single-site rodent protocols
1.9%
1.0×
Normal
Bar: record-rework-rate lift vs. the single-site rodent baseline · scale 0–4.0× · tick marks the 2.0× review threshold2 of 4 slices over threshold
Evidence-linked improvement
No cycle closes without a new case
The loop shuts when the lapsed protocol is a regression case. That suite is what the next review calendar built is measured against.
Improvement cycle · five stagesSwitchback — the path turns at Improve and returns at Learn
01Detect
Record-rework rate rises in a protocol slice.
02Diagnose
The protocol that expired between the study and the paper is read back until the cause narrows to one.
03Improve
Any change ships with a number, and the protocols attach to it.
04Verify
One protocol case still failing is enough to hold the release.
05Learn
One case joins the suite, one line joins the programme record.
Learn → DetectThe return edge. The next calendar is built 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, governance workflow, evaluation, integration, then production validation and handover.
WorkstreamWeek 1Week 2Week 3Week 4Week 5Week 6
01Programme workflow and escalation-boundary definition.
02Protocol and vivarium source assessment.
03Interval, amendment and training-currency mapping.
04Protocol-record ingestion and mapping.
05Calendar logic and finding-date binding.
06Confidence scoring and record routing.
07Committee review workflow.
08Protocol and vivarium-system integration.
09Calendar and currency cases.
10Guardrails and reporting controls.
11Protocol-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 programme, one committeeProductionProduction protocol systemsAdvancedMultiple assurances / sites
Introduced at Pilot
Clocks run to your intervals✓✓✓
Committee review✓✓✓
Calendar-currency baseline✓✓✓
Introduced at Production
Reporting by species group—✓✓
Review workflow in your systems—✓✓
Approved write-back—✓✓
Protocol-system integration—✓✓
Introduced at Advanced
Multi-regulator interval rules——✓
Multi-stage committee reviews——✓
High protocol volume——✓
Multi-assurance reporting controls——✓
Build priceFrom $5,000From $8,000Custom quote
Final build priceConfirmed after discovery based on integrations, workflow complexity, protocol volume, 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
01Your protocol list and species groups→Protocol-record ingestion and mappingWeek 1
02Representative protocols and semiannual reports→Calendar baseline, interval extraction and record bindingWeek 2
03Your interval, escalation and reporting rule sources→Interval, amendment and training-currency mappingWeek 1
04Access to relevant APIs, feeds or exports→Protocol, vivarium and training assessment, then integration setupWeek 2
05Programmes you would not want inspected→Expiry cases and the evaluation suiteWeek 4
06What no annual report may omit→Confidence scoring, record routing, guardrails and reporting controlsWeek 3
07Named committee members to read records→Committee 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
What fixes each width is elapsed time and not layout, so the fifth band honestly carries a pair.
PhaseW1W2W3W4W5W6
DiscoveryW1
BuildW2 – W3
EvaluateW4 – W5
Pilot & LaunchW5 – W6
Week focusW1Programme workflow discovery, interval mapping and the escalation boundaryW2Protocol, vivarium and training integration and the calendar baselineW3Governance workflow, confidence logic and committee-review controlsW4Evaluation suite, interval checks and failure-mode testingW5Reporting-system integration, pilot protocols and targeted correctionsW6One semiannual cycle run under the attending veterinarian, then Agent Care handover
Reading the bandA bar covers the weeks its work is named in, and nothing else. The week 5 overlap is real, not padding.
At the end of W6Once the review calendar validates, Agent Care assumes the agent.
DurationSix-week plan shown · typical delivery 4–6 weeks depending on scope confirmed in discovery.
Next step · Biotechnology AI agent
Build a governance agent that will not let a protocol lapse quietly.
Show us your protocol list, your semiannual calendar and who signs. Your IACUC coordinator already knows which protocol is closest to expiry and cannot prove it to anybody else. We sell calendar, completeness and record — not approval throughput, not faster approvals, and not less committee friction, because some of that friction is the committee doing its job. Two annual reports fall on 1 December, harmonised onto that date by NOT-OD-20-109 of 21 May 2020, and they describe two populations that will never tie: the Animal Welfare Act definition at 7 U.S.C. 2132(g) excludes purpose-bred rats and mice and birds, while PHS Policy covers all live vertebrates. We hold both from one record and show why the two counts differ. If a date we tracked is wrong after the annual report is signed, the unwind is a preliminary report, a corrective plan and a final report the institutional official signs, plus a re-examination of the tracker that failed. One refusal, stated in front: we do not write the alternatives-search narrative required by 9 CFR 2.31(d)(1)(ii). The regulation requires that the investigator considered alternatives, and the narrative is the evidence of that consideration — so automating it produces a compliant artefact of a deliberation that never happened. Our research-literature copilot, on the shelf next door, runs a recorded search, screens records against stated criteria and extracts outcomes into an evidence table; it could draft this narrative tomorrow, and we will not point it here. We will tell you the narrative exists, when it was written, which databases and date ranges the investigator recorded, and whether it was copied from another protocol. Prompt reporting to OLAW runs on NOT-OD-25-148 of 20 January 2026, which replaced the notice rescinded that day and sets no day count, so we age it and do not invent a deadline. We found no regulator-published deficiency or citation rate, so nothing here rests on one.
