What challenges did Yseop face before AI implementation?

Regulatory writing is time-consuming and demands accuracy, traceability, and compliance across clinical, safety, and CMC workflows. Manual drafting and QC slow the production of submission-ready documents.

What was the impact of the AI solution?

It reduces the time to create patient narratives from hours to seconds. It removes manual QC tasks through built-in validation, audit trails, and formatting. It helps life sciences teams improve report quality, retain talent, and meet deadlines with confidence.

Source

MicrosoftEvidence: Medium50/100

Automate Medical & Regulatory Authoring Workflows with Yseop Copilot

Use case typeMedical writing automationUpdated Jun 26, 2024

Yseop Copilot automates compliant document generation across clinical, safety, and CMC workflows directly in Microsoft Word and Veeva Vault. The platform supports regulatory writing for life sciences teams by generating source-driven drafts, live updates, and submission-ready dossiers. It covers core eCTD document types including Clinical Study Reports, Investigator’s Brochures, and Informed Consent Forms.

Organization: Yseop
Industry: Pharma
Location: France
Published: June 2024

Reported outcomes

1-3 $M-$3M

accelerated revenue per day sooner to marketRevenue & growth

−99.9%patient narrative creation time

Strategic outcomes

Risk & complianceAccelerated regulatory document productionRisk & complianceImproved submission compliance and traceabilityCost efficiencyEliminated manual quality control stepsMarket & geographic expansionEarlier drug and vaccine market entry

Why do we believe this?Outcome claims, sources, and evidence checks

Normalized claim

Patient narrative creation time: 99.9% decrease

YseopJun 26, 2024Customer storyInferred claimMedium evidence strength

it takes 4 seconds to write an unlimited number of them

Normalized claim

Accelerated revenue per day sooner to market: 1-3 $M-$3M increase

YseopJun 26, 2024Customer storyExplicit claimMedium evidence strength

Each day that a new drug or vaccine gets to market sooner, it creates $1-3 Million in accelerated revenue

Why do we believe this deployment?Customer identity, provider attribution, maturity, and source checks

Customer: Yseop, Eli Lilly, Sanofi
Provider: Microsoft
Maturity: Unknown
Linked source: Yseop

No explicit deployment-stage evidence found.

Customer identity supportedSource describes one deploymentMaturity evidence evaluated

Primary read

Use case focus

Showing 3 of 3

1Medical writing automation
2Document automation
3Workflow automation

Regulatory writing is time-consuming and demands accuracy, traceability, and compliance across clinical, safety, and CMC workflows.
Manual drafting and QC slow the production of submission-ready documents.

Yseop Copilot generates fully formatted documents from structured and narrative sources directly in Microsoft Word and Veeva Vault.
It supports live updates and content reuse across documents, templates, and regions, with built-in QC, audit trails, and formatting for eCTD delivery.
The platform uses a configurable studio with no code required and a multimodal approach using LLMs.

Technologies

Microsoft Word Veeva Vault Azure OpenAI Power Platform

It reduces the time to create patient narratives from hours to seconds.
It removes manual QC tasks through built-in validation, audit trails, and formatting.
It helps life sciences teams improve report quality, retain talent, and meet deadlines with confidence.

Architecture

Yseop Copilot integrates with Microsoft Word and Veeva Vault, uses a configurable studio with no code required, and combines structured/narrative sources with LLMs, live updates, reuse, built-in QC, audit trails, and eCTD submission assembly for regulated document workflows.

Sources & evidence1

Evidence: Medium50/100Evidence strength