Keep the disclosure record current: which regime each trial sits under, the clocks that follow, and what the registry record still lacks — then hold it for the named responsible party, who submits.
A study enrols its first participant, and the registration clock runs from that date, not from site activation.
02
A protocol amends, and the registry record is diffed field by field against the version that superseded it.
Reason
03
A primary completion date is reached, and the results clock is read from that date, not from study completion.
04
A results package is assembled, and the elements the rule enumerates are checked present or named as missing.
05
A trial ends in a Member State, and the notification clock runs there, the Article 37 results clock from the last one.
Decide
06
A record ages, and the verification and update clocks under 42 CFR 11.64 are counted from each element changed.
07
A certification falls due, and the evidence for each trial treated as in scope is gathered into one file to sign.
Out
08
A Pre-Notice arrives, and the cure period is tracked from receipt against the actions still open on the record.
09
A write action runs only inside the approval boundaries agreed during implementation.
→Product statement
The agent assembles and keeps the record current; the named responsible party registers, submits and certifies, and the sponsor answers for what the registry shows.
Example workflow
One trial, record to submission
AgentHuman
1Trial record receivedRegistry export, protocol, statistical analysis plan and trial register
2Record assembledClocks, required elements, protocol diffs and open items, each with its named source
3Disclosure pack draftedRegistry record, results elements, open items and confidence
4Controls appliedClock arithmetic, completeness tests against the rule, protocol diffs and confidence threshold
No human action required
Stages 1 to 4 run unaided, and nothing is submitted at any of them — the agent is assembling a record, and the responsible-party lane opens at the confidence gate.
5DecisionBranches at the confidence threshold
High confidence
Goes to the responsible party.
Low confidence
Adds a disclosure-lead read first.
Responsible party
The pack is held with its source records, its open items and the confidence.
Approve · Amend · Send to disclosure review
Approved — released to submit▼
6Disclosure register updatedOnly where write access and approval policy allow it
7Outcome evaluatedAmendment distance, open-item outcomes, registry acceptance and post-posting corrections
Amendments
Each amendment the responsible party makes is counted in the evaluation.
What should not run autonomously
Human approval stays in control
Outside the boundary — human approval required8 items
Submitting a registration or a results record.
Deciding whether a trial is an applicable clinical trial.
Signing the certification of compliance.
Requesting an extension, or appealing a refusal.
Automation boundaryAgent acts unaided
✓Assemble the registry record against the protocol and the analysis plan.
✓Compute each clock from the dates already on the record.
✓Test the results package against the elements the rule enumerates.
✓Name what is missing or inconsistent, and hold the pack for the party.
Writes run only inside the boundaries agreed at implementation, and never ahead of a submission.
Setting the primary completion date, or revising it.
Answering a Pre-Notice or a Notice of Noncompliance.
Placing or validating a document in a submission.
Changes to clock, scope or approval rules.
Example output
One disclosure item, annotated
Everything the agent assembles is attached to the record it was drawn from.
Disclosure record output · single trialIllustrative example
Trial
Disclosure item
Time to deadline
Source of record
Confidence
Party of record
Interventional, US site
Results due one year from the actual primary completion date
138 days
Registry record on file
88%
Responsible party, named on the record
As receivedTaken from the registry record and the protocol on file — nothing on this side is written by the agent.
Source facts usedRegistry record, datedProtocol, version on fileAnalysis plan section
Why this is openThe clock runs from the primary completion date — 42 CFR 11.44(a).
ActionApproveAmendSend to disclosure review
What the score decidesBelow the configured threshold the item picks up a disclosure-lead read before the party sees it.
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 trialFrom the registry record
03Assembly
Read the record against the rule
The protocol is read for what the registry record must say — not for what should have happened to a subject at a site.
01Approved path
The responsible party certifies
The obligation is personal under 42 CFR 11.4. A named person signs Form FDA 3674; the agent builds the evidence file behind it and signs nothing.
02Human review
A posted record is corrected in public
After a record is posted, an error is corrected on the clock 42 CFR 11.64(b) sets, in a registry anyone can read, under the name of the party who submitted it.
04Build an evidence trail
The record, the clock it was measured against and the party who certified stay on the registry.
Integrations
Typical integrations
Five system groups connect to the same agent. Which of them are in scope is decided in discovery.
Public registriesClinicalTrials.gov PRS CTIS · EudraCT
Clinical data systemsMedidata Rave · Veeva Oracle Clinical One
Study documentsProtocol · SAP · CSR Trial master file
Agent
Trial disclosure record
Reads the record Assembles the pack Holds for the party
Registers and submissionsTrial register · CTMS Regulatory publishing
A portfolio-wide on-time posting rate can read as healthy while a few trial types carry most of the returned items. Nestack reports the return rate by trial type, not only in total.
Slice performance — reported separately, not only in aggregateIllustrative example
Slice
Failure rate
Lift
Lift vs. threshold
Status
Partner-run and licensed trials
9.4%
3.7×
Review
Trials with a delay certification
7.6%
3.0×
Review
Historical CTIS records
4.1%
1.6×
Watch
Single-sponsor US-only trials
1.7%
0.7×
Normal
Bar: return-rate lift vs. single-sponsor baseline · scale 0–4.0× · tick marks the 2.0× review threshold2 of 4 slices over threshold
Evidence-linked improvement
Each cycle ends with one more test
A cycle closes when the missed posting is a regression case. That suite is what the next record submitted is measured against.
Improvement cycle · five stagesSwitchback — the path turns at Improve and returns at Learn
01Detect
Return rate rises for one trial type.
02Diagnose
The study that closed in March and posted the following spring is read back until the cause narrows to one.
03Improve
The change ships with a number, and the trials that forced it travel beside it.
04Verify
Nothing releases while one touched registry case is still red.
05Learn
It is kept for good, and the clock rules are amended in the same commit.
Learn → DetectThe return edge. The suite the next detection runs against is 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, registry workflow, evaluation, integration, then production validation and handover.
WorkstreamWeek 1Week 2Week 3Week 4Week 5Week 6
01Disclosure workflow discovery and boundary mapping.
02Registry and trial-source assessment.
03Scope, clock and results-completeness mapping.
04Record ingestion and reconciliation.
05Pack assembly and source binding.
06Confidence scoring and exception routing.
07Responsible-party review workflow.
08Registry and document integration.
09Clock and completeness cases.
10Guardrails and certification controls.
11Registry-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 registryProductionProduction registry systemsAdvancedMultiple regions / registries
Introduced at Pilot
Disclosure record and reconciliation✓✓✓
Responsible-party approval✓✓✓
Record-completeness baseline✓✓✓
Introduced at Production
Reporting by registry—✓✓
Exception workflow in your systems—✓✓
Approved write-back—✓✓
Registry-platform integration—✓✓
Introduced at Advanced
Multi-regime clock rules——✓
Multi-stage disclosure approvals——✓
High trial count——✓
Multi-regime disclosure controls——✓
Build priceFrom $5,000From $8,000Custom quote
Final build priceConfirmed after discovery based on integrations, workflow complexity, trial count, 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 trial list and the regimes they sit under→Scope, clock and results-completeness mappingWeek 1
02Representative prior disclosure packages→Record ingestion, reconciliation and the assembly baselineWeek 2
03Your protocols, analysis plans and study reports→Disclosure-record mapping and automation-boundary definitionWeek 1
04Access to relevant APIs, feeds or exports→Registry and document assessment, then integration setupWeek 2
05Records you would not want re-read→Deadline cases and failure-mode testingWeek 4
06What no certification may cover→Confidence scoring, item routing, guardrails and certification controlsWeek 3
07Named responsible parties to review the pack→Responsible-party 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
The bands here follow the weeks each phase truly fills, and that is why the fifth carries two of them.
PhaseW1W2W3W4W5W6
DiscoveryW1
BuildW2 – W3
EvaluateW4 – W5
Pilot & LaunchW5 – W6
Week focusW1Disclosure workflow discovery, rule mapping and the automation boundaryW2Registry integration and the reconciliation baselineW3Assembly workflow, clock logic and review controlsW4Evaluation suite, clock checks and failure-mode testingW5Document integration, a pilot programme and targeted correctionsW6One posting cycle run under the responsible party, then Agent Care handover
Reading the bandA bar spans the weeks its own work is named in, and no others. The week 5 overlap is real, not padding.
At the end of W6Validation closes on live trials, and Agent Care picks up the monitoring.
DurationSix-week plan shown · typical delivery 4–6 weeks depending on scope confirmed in discovery.
Next step · Biotechnology AI agent
Build the disclosure record before the next clock falls due.
Show us your trial list, your clocks and who signs. If a trial in your portfolio was judged out of scope by somebody who has since left, then that judgement is on nobody's file, and the certification signed over it cannot be audited by the person who signed it. FDA wrote to sponsors and researchers on 30 March 2026 about registered trials with no results submitted, and announced it on 13 April 2026.
