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Biotechnology AI agent · Medical writing

Medical-Writing & CSR-Authoring Copilot (Study Reporting)

Draft study-report sections, protocol text and narratives from the locked dataset and your own templates, with numbers tied to the outputs they came from — the medical writer and the study statistician approve.

Typical delivery
4–6 weeks
Deployment
Your stack
Sign-off
Never the agent
After launch
Agent Care

What this agent does

Writes what the outputs already say

In

  1. 01

    Take the locked dataset version, the tables, listings and figures approved for it, and the analysis plan behind them.

  2. 02

    Read the document template, the previous draft of each section and the wording the study already carries.

Reason

  1. 03

    Draft each section into your own template, to the content the guideline prescribes for that section.

  2. 04

    Bind the numbers and statements in the text to the table, listing or figure they were taken from.

  3. 05

    Compare the dataset version in scope with the one the last draft was written from, and mark what moved.

Decide

  1. 06

    Hold text whose figure no longer matches its source, and wording carried in from a template or a prior study.

  2. 07

    Route interpretation, the choice of analysis and anything the outputs do not carry to the writer and statistician.

Out

  1. 08

    Present the drafted section beside its outputs, the version it was written from and what changed since the last draft.

  2. 09

    Retain the source of each figure quoted, the template used, the reviewer edits and the version behind the draft.

Product statement

The agent drafts and traces inside the approval boundaries agreed during implementation. Interpretation, the conclusion, the choice of analysis and approval of a report, protocol or amendment stay with your writer, statistician and medical lead; the sponsor answers for the filing.

Example workflow

One report section, end to end

  1. 1Section openedThe reporting plan after database lock, an amendment, or a question the medical lead has raised
  2. 2Sources resolvedDataset version, the outputs approved against it, the analysis plan in force and the section template
  3. 3Section draftedWritten into your template, each number and statement carried from the output it was read out of
  4. 4Controls appliedNumber-to-output checks, prescribed-content checks, carry-over checks, version comparison and confidence threshold

No human action required

Stages 1 to 4 run without a person in the loop — drafting and the source checks finish first, because a section whose figures have not been checked wastes the review it goes into.

5DecisionSplits on the source checks and the confidence threshold
Figures agree with their outputs

Joins the pack the reviewers read.

A figure or a claim will not source

Held beside the output it disagrees with.

Writer and statistician review

The section is held beside its outputs, the dataset version it was written from and the text the agent could not source.

Accept · Rewrite · Query the statistician

Accepted — handed back

  1. 6Draft joins the review packWritten to the document system only where access and approval policy allow; nothing is approved or signed
  2. 7Outcome evaluatedSource-check failures, text the writer rewrote, prescribed content missed and what the statistician sent back

Rewrites

Lines the writer rewrote before the pack went out are counted in the evaluation.

What should not run autonomously

Human approval stays in control

Outside the boundary — human approval required

8 items

  • Approving or signing a study report.
    • Approving a protocol or an amendment.
    • Interpretation, and any conclusion about a result.
    • Choosing which analysis a section presents.

  • Automation boundary

    Agent acts unaided

    • ✓Draft each section into your template, to the prescribed content.
    • ✓Bind each number in the text to the output it came from.
    • ✓Compare dataset versions and mark what moved.
    • ✓Hold unsourced text and carried-over wording for the writer to read.

    Write actions run only inside the approval boundaries agreed during implementation. Signing a report is not one of them.

    • Any comparative or off-label statement.
    • Changing a number so the text agrees.
    • Deciding a prescribed section element does not apply.
  • Changing templates, drafting rules or the dataset in scope.

Example output

One drafted section, annotated

Everything the agent writes is attached to the output and the dataset version it was read from.

Drafted section · single study report

Illustrative example
Document
Clinical study report
Section
Adverse-event summary
Dataset
Lock 2, current
Draft handed to
Writer, unapproved
Confidence
93%
Held for
A figure from lock 1

As received

The document, the section and the dataset version the reporting plan puts in scope.

Evidence used

  • Locked dataset, lock 2
  • Approved output tables
  • Section template

Why it stops here

A figure traces to a table from the previous lock, so the text is held, not edited to agree.

What the score decides

Confidence sets how closely the writer reads it, not whether a figure is right.

Action

AcceptRewriteQuery the statistician

Value

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 section in the plan

From the reporting plan after lock

03Drafting & tracing

Keep the text tied to the outputs

Use the approved template, the analysis plan and the outputs produced against this dataset version.

01Approved path

Stop re-keying numbers by hand

Each figure in the text arrives with the table, listing or figure it came from, at the version it was read at.

02Human review

Make carried-over text visible

Wording reused from a template or a prior study, and text no output supports, are marked in the draft rather than reading like the rest.

04

Build an evidence trail

Retain the dataset version, each figure's source output, the template used, the confidence, the evaluator result 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.

  • Authoring & templates

    • Microsoft Word
    • Veeva Vault RIM
    • Template and style libraries
    • SharePoint

  • Statistical outputs

    • TFL packages
    • define.xml
    • SAS and R outputs
    • analysis metadata

  • Study data

    • ADaM and SDTM datasets
    • data-lock records
    • Medidata Rave
    • Veeva CDMS

Agent

Medical writing & CSR authoring

  • Drafts the section
  • Traces each figure
  • Holds unsourced text

  • Safety & narratives

    • Oracle Argus
    • ArisGlobal LifeSphere
    • Narrative templates
    • CIOMS forms

  • 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 study report

Each control wraps the one inside it. A section clears every layer before a reviewer reads it, and approval sits outside all six.

L6 · Outermost — last line of defence

Inward → L1 · closest to the model

L6Rollback / safe modeReturn drafting to your writers if evaluations or production signals degrade.Roll back
L5Version trailRecord the dataset version, source output, template, edit and who made it.Record
L4Reviewer gateDefine what may reach the pack; approval and sign-off stay with named people.Gate
L3Carry-over checkRead reused template and prior-study wording against this study's own facts.Check
L2Template and scopeRestrict wording to the approved template, the analysis plan and what the outputs carry.Restrict
L1Source bindingTest each figure in the text against the output it cites; a mismatch is held.Hold
Model coreSection drafted — text in your template, each figure with its source output, the dataset version and confidence
L1 – L2
Test the text against its outputs
L3
Reads reused wording against this study
L4 – L5
Leave approval to a person, keep the trail
L6
Pulls automation back when signals degrade

How Nestack evaluates it

Evaluate what the text rests on, not only how it reads.

Coverage runs the whole depth of the workflow, and every layer is cut by slice. The number checks run before anything reaches a reviewer.

Surface — the drafted section the writer opens

  1. E1Final-output evaluationDid the section carry the content the guideline prescribes for it?
  2. E2Source-binding evaluationDoes each number in the text match the output it cites?
  3. E3Version evaluationWas every figure read from the dataset version in scope?
  4. E4Carry-over evaluationDid template or prior-study wording survive into this study's text?
  5. E5Slice evaluationHow does performance change across specific document cohorts?
  6. E6Business outcomeHow much did the writer rewrite before the pack went to the medical lead?

Floor — the report the medical lead is prepared to approve

Failure modes

Where each failure originates in the agent

Seven failure modes plotted against the five stages of the agent lifecycle.

Agent lifecycle

Direction of processing →

  1. 01 · Intake / retrieval

    2 modes

    • MW-01

      Drafted from a superseded lock

      Figures come from outputs the current lock replaced.

    • MW-02

      Output does not exist yet

      A table the section needs was never programmed.

    Stage gathers

    The dataset version, the outputs and the templates

  2. 02 · Drafting

    2 modes

    • MW-03

      Wording edges into interpretation

      A results sentence starts to explain the numbers.

    • MW-04

      Narrative smoothed past the record

      A case reads tidier than its source documents.

    Stage writes

    The section text, in your own template

  3. 03 · Source checks

    1 mode

    • MW-05

      Right figure, wrong analysis set

      The number sits in a table, but not in that one.

    Stage checks

    Each figure against the output it cites

  4. 04 · Pack / output

    1 mode

    • MW-06

      Sections disagree with each other

      Two sections report the same population differently.

    Stage returns

    The draft the writer and statistician read

  5. 05 · Change / Version

    1 mode

    • MW-07

      Output rerun under a finished draft

      The table moves after the section was written.

    Stage tracks

    Model, prompt, template and output changes

  • Sev-1 · unsupported text goes up for approval
  • Sev-2 · a figure no longer matches its source
  • Sev-3 · drafting degrades, the section is held
See the complete Biotechnology failure-mode catalogue

Affected slices

Where the source moved, the text gets rewritten

Cohorts here are document types, not studies. The number is drafted lines a writer rewrote or a statistician sent back — narratives written from documents that disagree, and re-locked sections carrying the last draft's figures.

Slice performance — reported separately, not only in aggregate

Illustrative example
SliceFailure rateLiftLift vs. thresholdStatus
Serious-event patient narratives3.9%2.5×Review
Sections redrafted after a re-lock3.4%2.2×Review
Text reused from prior studies2.5%1.6×Watch
Routine template-led sections1.4%0.9×Normal

Bar: corrected-line lift vs. template-led baseline · scale 0–4.0× · tick at the 2.0× threshold

2 of 4 slices over threshold

Evidence-linked improvement

Two drafts of the same section should not fail the same way

A line the statistician sent back points at the source map, the template or the number check behind it. The change goes there, before the next section.

Improvement cycle · five stages

Switchback — the path turns at Improve and returns at Learn

  1. 01

    Detect

    One document cohort's corrected lines move away from the rest.

  2. 02

    Diagnose

    These live in the step between an output and a sentence.

  3. 03

    Improve

    The source map, template or check moves through your change control first.

  4. 04

    Verify

    Sections that failed are written again from the dataset version in force.

  5. 05

    Learn

    The corrected line is kept, and the wording the writer chose sits in the template.

  6. Learn → Detect

    The return edge. A report already approved is not quietly re-cut — the change is recorded and reaches the next draft a writer opens.

Typical build scope

Twelve workstreams across six weeks

The build scope read against the delivery timeline. Week structure follows the six-week plan — discovery, templates and outputs, drafting and source binding, evaluation, integration, then production validation and handover.

Workstream

Week 1Week 2Week 3Week 4Week 5Week 6

  1. 01Workflow discovery and boundary definition.Week 1
  2. 02Document set, templates and section map.Week 1, Week 2
  3. 03Dataset version and output-package access.Week 1, Week 2
  4. 04Source binding from text to table, listing or figure.Week 2, Week 3
  5. 05Section drafting into your own template.Week 3
  6. 06Narrative drafting from case documents.Week 3, Week 4
  7. 07Carry-over and prior-study text checks.Week 3, Week 4
  8. 08Version comparison and change marking.Week 4
  9. 09Writer, statistician and medical lead review workflow.Week 4, Week 5
  10. 10Evaluation suite and regression sections.Week 4, Week 5
  11. 11Document-system integration and traces.Week 5, Week 6
  12. 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. No tier lets the agent approve a report or decide what a result means.

Capability✓ in scope · — not at this tierPilotOne document, one studyProductionProduction document-system integrationAdvancedSeveral studies and document types
Introduced at Pilot
Sections drafted into your templates✓✓✓
Figures bound to their source output✓✓✓
Dataset-version comparison✓✓✓
Carry-over and prior-study checks✓✓✓
Writer and statistician review✓✓✓
Baseline evaluation✓✓✓
Patient narratives from case documents✓✓✓
Introduced at Production
Document-system integration—✓✓
Observability and evaluation—✓✓
Introduced at Advanced
Several studies and document types——✓
Translation and enterprise controls——✓
Build priceFrom $5,000From $8,000Custom quote
Final build price
Confirmed after discovery based on the documents and studies in scope, template complexity, output and dataset access, document-system integration, 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.

  1. 01The document set and the template each section is written into

    Document set, templates and section map

    Week 1

  2. 02Who owns each section and who approves the finished report

    Approval-boundary definition and the review workflow

    Week 1

  3. 03Access to the locked datasets and the output packages

    Dataset version and output-package access

    Week 2

  4. 04The analysis plan and what was prespecified in it

    Source binding from text to table, listing or figure

    Week 2

  5. 05Case source documents for the narratives in scope

    Narrative drafting from case source documents

    Week 3

  6. 06The sections your writers rewrote most on the last study

    Evaluation suite, regression sections and failure-mode testing

    Week 4

  7. 07Named writers, a study statistician and a medical lead

    Review workflow, then pilot sections 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

Phases are drawn over the weeks they actually occupy. Source binding is built in week 2, because every check after it reads against that map.

Phase

W1

W2

W3

W4

W5

W6

  1. DiscoveryW1
  2. BuildW2 – W3
  3. EvaluateW4 – W5
  4. Pilot & LaunchW5 – W6

Week focus

W1Boundary, document set and the sections in scope

W2Template mapping, dataset access and source binding

W3Drafting into your sections, and the first narratives

W4Version comparison, carry-over checks and the evaluation suite

W5Document-system integration, first drafted sections and corrections

W6Your writers work from live sections, then Agent Care handover

Reading the band
Bars are drawn from the work, not from a phase plan. No section is drafted before week 3; text cannot be bound to outputs that nobody has finished mapping.
At the end of W6
A section of a live report has been drafted, checked against its outputs and rewritten where your writer disagreed. From week 7 the source checks and the version comparison are Agent Care's problem rather than your writer's.
Duration
Six-week plan shown · typical delivery 4–6 weeks depending on scope confirmed in discovery.

Next step · Biotechnology AI agent

Build a writing copilot around the study you have just locked.

Show us one report section, the outputs it is written from and how a draft reaches your medical writer and your statistician today. A copilot that writes well and sources badly is worse than no copilot, so the first three weeks go on the map from text to table, listing and figure, at the dataset version each was read at.

Typical delivery
4–6 weeks
Deployment
Your document and study stack
Sign-off
Your writer and medical lead
After launch
Agent Care available

Nestack Agents · Medical writing & CSR authoring

AGT-BT-08 · Agent Care available after launch

Build a medical-writing copilot

Four questions so the call starts from your actual setup — then pick a time that suits you.

About you
Your setup

No obligation. We’ll map the workflow, name the automation boundary and tell you if an agent is the wrong answer.