Softpiper Solutions

Healthcare and life sciences · Documents and back office

Clinical and regulatory document drafting

Draft protocols, SOPs, discharge summaries and submission sections from approved sources with Claude, with citations, template checks and expert sign-off.

  • ClaudeAnthropic
  • GeminiGoogle
  • Typical timeline: 4–8 weeks

The problem

Protocols, SOPs, discharge summaries and regulatory submissions take weeks of expert writing and several rounds of review.

  • Experts spend their time assembling documents, not deciding.
  • Each document repeats content that already exists elsewhere.
  • Formatting and consistency issues surface late in review.

How we solve it

Claude drafts each document from your approved sources, cites every claim and formats it to your template; a reviewer agent checks it before your experts edit and sign off.

It plugs into SharePoint or Google Drive, QMS / DMS exports and Microsoft 365 or Google Workspace, so nothing you rely on today is replaced. The architecture below shows each step and which model does the work.

Architecture

From your stack, through the AI layer, to numbers you can track

Each step names the model or system doing the work. Writes to your systems wait for a person to approve them.
Clinical and regulatory document drafting. Your systems (SharePoint or Google Drive, QMS / DMS exports and Microsoft 365 or Google Workspace) connect to Softpiper's AI layer, which runs these steps: Assemble the source pack (Drive / SharePoint); Draft with citations (Claude Opus); Format to template (Agent Skills (docx, pdf)); Template check (Claude reviewer); Expert review and sign-off (Version history); Literature review (Gemini Notebook). Outcomes are measured as drafting cycle time, review rounds per document, citation coverage and error and rework rate.

Your stack

  • SharePoint or Google Drive
  • QMS / DMS exports
  • Microsoft 365 or Google Workspace

AI layer

Softpiper AI layer

  • Claude
  • Gemini
  1. Assemble the source pack, using Drive / SharePoint

    Approved sources (prior documents, data tables, references) are gathered per document from SharePoint or Drive.

  2. Draft with citations, using Claude Opus

    Each section is drafted from the source pack, citing the passages it used.

  3. Format to template, using Agent Skills (docx, pdf)

    Drafts are produced as formatted Word or PDF files that follow your template.

  4. Template check, using Claude reviewer

    A reviewer agent checks structure, required sections and citation coverage, and lists the gaps.

  5. Expert review and sign-off, using Version history

    Your experts edit, approve and sign; every version is kept.

  6. Literature review, using Gemini Notebook

    Staff explore source literature in a grounded notebook.

Outcomes you measure

  • Drafting cycle time
  • Review rounds per document
  • Citation coverage
  • Error and rework rate

Why this model

Claude and Gemini, each where it leads

We choose per task on capability, cost and where your data must stay. Final versions are picked at kickoff.
ClaudeAnthropic

Claude's most capable models handle long, multi-document drafting with citations, and Agent Skills produce formatted Word and PDF files. A second Claude pass checks each draft against your template.

GeminiGoogle

Gemini Notebook gives your team a source-grounded space for literature review alongside the drafting workflow.

Delivery

What you get, how long it takes, and how we keep it safe

Guardrails

  • A qualified person reviews and signs off every document.
  • Every claim cites an approved source; uncited text is flagged.
  • Full audit trail and version control.
  • Patient-identifiable data is minimised or removed before drafting.

Plus the guardrails on every build: facts from your systems, approvals for writes and money, a human one step away, audit logs and evals. See all

Deliverables

  • Templates and source-pack structure
  • Drafting workflow with citations
  • Template-check reviewer
  • Formatted Word and PDF output
  • Audit trail

Typical timeline

  1. Templates, drafting workflow and reviewer4–8 weeks

A planning range for a first production release. We confirm scope, price and dates in a tailored proposal.

KPIs to track

  • Drafting cycle time
  • Review rounds per document
  • Citation coverage
  • Error and rework rate

Goals we agree with you and measure from a baseline. They are what we track, not results we promise.

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Pip · Softpiper's AI

Ask Pip about this playbook

Ask Pip how this would work for you

Pip is Softpiper's AI. Tell it what you run today and it will walk through how this playbook fits, what we would build first and a tailored price range. Or book a call with the team.

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