Clinical and regulatory writing

The first draft, with every number sourced.

An operator drafts the section from your protocol, SAP and tables, in your own template. It checks each number against its table. Your writer edits and signs off.

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  • ISO 27001
  • GDPR
  • Every run auditable
Illustrative draft
VRN-118-201 · Phase 2 · atopic dermatitisDraft 0217 · Verrin CSR template v4 (.docx)
§ 11.4.1Analysis of efficacy: primary endpoint

The primary endpoint was the proportion of participants achieving EASI-75 at Week 16.

In the full analysis set, 51 of 108 participants (47.2%) on VRN-118 200 mg achieved EASI-75, compared with 10 of 54 (18.5%) on placebo.

The difference was 28.7 percentage points (95% CI 14.7 to 42.7; p<0.001), from the Cochran–Mantel–Haenszel test stratified by baseline severity.

Writer sign-off

Waiting for a yes

Upload section 11.4.1 to SharePoint › CSR › VRN-118-201

A. Ferri, medical writing lead

Illustrative draft: a fictional study and numbers that show the output's shape.
  • up to 50%less drafting effort on CSRs and PSURs
  • 70%faster to a first draft
  • up to 80%less rework from checks run while drafting
  • 100+ hoursback per submission cycle

Enterprises running operators on Alomana

One section, start to finish

The groundwork of a first draft, checked the way a careful writer would.

  1. The sources

    Reads the protocol, SAP, tables and prior documents: PDF, Word or Excel

  2. The template

    Writes into your company template, with its headings and styles

  3. The draft

    Drafts the CSR section, narrative or response from the evidence

  4. The trace

    Notes the table or page behind every number it writes

  5. The cross-check

    Checks each number against its table in code and lists every mismatch

  6. Safety narratives

    Classifies SUSARs and drafts ICH E2B case narratives

How the operator drafts a section

  1. Connect

    SharePoint or Drive, plus a folder of templates, SOPs and prior submissions.

  2. Draft and check

    Your template, every number sourced and checked.

  3. Sign off

    Your writer edits and approves. Then it uploads and logs it.

Drafts for your writers, never filings.

The operator stops at a reviewed draft. Publishing and submission stay with your team.

  • It never files with an agency
  • Works from your PDF, Word and Excel files
  • Every number checked in code against its table
  • Your writer signs off on every section

Nothing leaves the team without a yes.

  • Uploads and messages wait for a person's yes
  • A declined action is not retried
  • Every run logged: input, output, tools, user
Measured on
  • Days to a first draft
  • Writer hours per section
  • Numbers corrected in QC
  • Review rounds per document
Works with
  • SharePoint
  • Google Drive
  • Confluence
  • Jira
  • Slack
  • A folder of templates, SOPs and prior submissions
  • Public FDA, EMA and ICH guidance
  • Your RIM or DMS via MCP
Built-in operators
  • Regulatory Affairs operator
  • Clinical Trial Analyst
  • Drug Safety Monitor
Trusted for
  • ISO 27001
  • GDPR
  • Never trains on your data
  • Single-tenant for enterprise

A custom operator typically goes live in up to 4 weeks.

Questions writing teams ask

What is a regulatory writing operator?

An autonomous agent that drafts clinical and regulatory documents from your own sources. It reads the protocol, SAP and tables, writes the section into your template, notes the source of every number, and checks each number against its table before your writer reviews it.

Does it file or submit anything?

No. It drafts for your writers and stops there. Uploading a draft to SharePoint or Google Drive waits for a person's yes, and publishing and submission stay with your team.

Which documents can it draft?

Sections of clinical study reports and protocols, safety narratives in ICH E2B format, and responses to agency questions, working from your protocol, SAP, tables and prior documents, in your own Word template.

How do our writers check what it wrote?

Every number shows the table or page it came from. The operator checks each number against its table in code and lists every mismatch it finds. Your writer edits, accepts or rejects, and signs off.

Does it connect to Veeva Vault or our EDC?

Not natively. It reads files from SharePoint, Google Drive or a knowledge folder you give it. Other systems, such as a RIM or document management system, connect through a remote MCP server for your deployment.

Is our study data private?

Alomana is ISO 27001 certified and GDPR-compliant, and your data is never used to train AI models. Enterprise deployments run single-tenant, in a dedicated instance, and every run is logged with input, output, tools and user.

Bring one section you wrote last month.

Talk it over with sales: what the operator needs from your systems, and how it goes live.

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Alomana is a secure enterprise AI platform where autonomous agents, called operators, run business processes end to end. Every run is fully auditable.