H1ST-AI-MWR-005
Your CSR shouldn't be weeks of transcribing figures
You should be shaping the story of the study, not retyping its numbers for the hundredth time. This agent builds a complete ICH E3 CSR using FDA, EMA, and PMDA submission templates, populating results sections from the actual TLFs and analysis datasets through retrieval-augmented grounding. The multi-week effort of drafting and reconciling a CSR shrinks, while you stay the medical writer of record.
The grind you know
The CSR is one of the longest, most repetitive documents you will ever author, and copying hundreds of figures from TLFs into prose by hand is both slow and easy to get wrong. Then come the review cycles, reconciling versions and keeping every in-text number synchronized with the outputs, that quietly consume weeks you don't have.
Part of the Medical Writing family
ICH E3 CSRs & patient narratives.
You should be shaping the story of the study, not retyping its numbers for the hundredth time. This agent builds a complete ICH E3 CSR using FDA, EMA, and PMDA submission templates, populating results sections from the actual TLFs and analysis datasets through retrieval-augmented grounding. The multi-week effort of drafting and reconciling a CSR shrinks, while you stay the medical writer of record.
Provide the protocol, SAP, TLFs, and datasets, and select the target regulatory template.
The agent drafts the ICH E3 sections and populates results from the outputs through retrieval-augmented grounding.
The medical writer reviews via track-changes, resolves comments, and remains the author of record for the final report.
Capabilities
Builds the report to the full ICH E3 section framework so nothing required for submission is missed.
Applies FDA, EMA, and PMDA submission templates so the CSR fits the target authority's expectations.
Pulls in-text figures from TLFs and datasets via retrieval so reported numbers stay tied to their source outputs.
Supports track-changes and comment handling across review cycles to streamline reconciliation.
In practice
Where the agent shows up in the day-to-day of a live trial — the moments the grind usually lives in.
The CSR needs hundreds of in-text numbers pulled from TLFs into prose. The agent populates the ICH E3 results sections via retrieval-augmented grounding, so you shape the study's story instead of retyping figures for weeks.
A refreshed output changes several results after drafting. Because in-text figures are pulled from the TLFs and linked to their source outputs, the numbers stay tied to the outputs rather than drifting out of sync.
You need an FDA version and a PMDA version of the report. The agent applies the region-specific submission template on top of the ICH E3 structure, so the CSR fits each authority without a manual reformat.
Proof
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Gemini / Anthropic LLM
LLM
Veeva Vault
EDC
Drafts study and results narratives and executive summaries grounded in your actual TLFs and datasets, ready for statistician review.
Learn moreProduces submission-quality tables, listings, and figures from ADaM datasets using a library of 100+ CDISC- and FDA-standard output templates.
Learn moreDrafts and refines patient safety narratives into consistent, regulation-aligned wording with full version control across the narrative set.
Learn morePeace of mind
Every output is generated inside a validated, audit-ready platform, kept under human-in-the-loop control, and mapped to the regulatory and CDISC standards this agent supports.
Walk through it on your own workflow with a clinical-trials expert — no pressure, no obligation, and honest answers, including on the limits.
