Biostatistics & Reporting · H1ST-AI-MWR-005
ICH E3 CSRs & patient narratives.
The problem this family owns
This is the stretch of the trial where the work is repetitive, deadline-bound, and unforgiving of small errors — the part a stretched team feels first, and the part where a missed detail is most expensive to fix later.
The Medical Writing family puts a purpose-built agent on each of these. You stay in control of every output — the agents absorb the grind, not the judgment.
Where it fits
Regulatory writing at draft-speed. Medical Writing assembles ICH E3 clinical study reports and patient safety narratives from the protocol, SAP, and statistical outputs — with a human author always in control.
It sits in the Biostatistics & Reporting suite — submission-ready datasets, outputs, and reports — and is delivered as 2 individually-deployable AI agents you can adopt one at a time or as a complete workflow.
The agents
Each agent below removes a specific piece of that grind. Deploy the whole family as one workflow, or add the single agent that hurts most today and expand from there.
Assembles ICH E3-structured Clinical Study Reports that pull results directly from your TLFs and datasets, with full track-changes review support.
Learn moreDrafts and refines patient safety narratives into consistent, regulation-aligned wording with full version control across the narrative set.
Learn moreOne workflow, not point tools
Enabled together, the Medical Writing agents hand off in sequence — each one's output becomes the next one's input, so nothing is re-keyed and nothing falls between the seams.
Assembles ICH E3-structured Clinical Study Reports that pull results directly from your TLFs and datasets, with full track-changes review support.
Drafts and refines patient safety narratives into consistent, regulation-aligned wording with full version control across the narrative set.
Built for regulated trials
Every agent runs inside a validated, audit-ready platform aligned to the standards clinical teams and inspectors expect.
Electronic records and signatures with full audit trails, access controls, and validation.
Good Clinical Practice, including risk-based quality management and computerized-system expectations.
Standards-based data capture, tabulation, and analysis datasets that validate clean in Pinnacle 21.
PHI safeguards, de-identification, and role-based access across the platform.
Lawful processing, data-subject rights, and EU data-residency support for global trials.
Security, availability, and confidentiality controls audited against Trust Services Criteria.
Certified information-security management system governing the whole platform.
AI management system for responsible, governed, and auditable use of AI.
Straight answers
Pulled from the questions teams ask most about the agents in this family — answered plainly, including where the honest answer is a limit.
No pitch, no pressure — a working walkthrough on your own workflow and honest answers, including on the limits. Bring the study that worries you most.
