AI CSR writing tool — drafts in days, not months.
Asthra is an AI CSR writing tool that generates ICH E3–aligned clinical study report first drafts from your protocol, SAP, and TFL package — section by section, with sentence-level provenance. Writers stay in Word, focused on judgment instead of grunt work.
What you bring to the draft.
Asthra works from the same source set your writers already use. Upload, classify, approve.
Trial Protocol
Including amendments. Asthra extracts study design, endpoints, populations, and randomization rules.
Statistical Analysis Plan
Analysis methods, populations, missing-data rules — used to write the methods and analyses sections.
TFL Package
Tables, figures, and listings. Indexed table-by-table; cells become sentence-level citations.
Investigator Brochure
Background and prior data — informs introduction and clinical context sections.
Prior CSRs
Optional. Used as style reference and for cross-trial consistency, not as a source for new claims.
Your CSR Template
Asthra writes into your house template — section numbering, headings, table-of-contents, and styles preserved.
From source set
to submission-ready draft.
Upload & classify (~30 min)
Drop your protocol, SAP, and TFL package into the project. Asthra classifies each file, extracts structure, and surfaces any ambiguity for writer review.
Approve the retrieval plan (~15 min)
Asthra proposes a section-by-section plan: which file each part will draw from. Edit, swap sources, or exclude material out of scope. Approve once.
Generate the first draft (~3–6 hours)
Asthra drafts all 38 sections in a single run, with citations attached at the sentence level. The end-of-run QC pass runs automatically — cross-references, statistical-claim binding, defined-term ordering, citation density, gap detection, hyperlink resolution — and ships as a structured report alongside the draft. Gap flags surface where source data is missing or contradictory.
Writer review in Word
Writers open the .docx, review with track changes, and chat with Asthra in the task pane to refine sections, swap sources, or fill gaps. Every refinement is logged.
Hand off for medical review & sign-off
Final draft ships with the audit ledger and QC report embedded. Medical reviewers use the same citation graph to verify clinical claims — no extra tooling required.
What changes for the writing team.
Manual CSR drafting
- −8–12 weeks to first complete draft
- −~60% of writer time on copy-paste, reformatting, and table summarization
- −Source-to-claim verification done section-by-section, manually
- −Cross-section consistency depends on writer memory
- −Audit trail reconstructed from email and version history
CSR drafting with Asthra
- +First draft in days; writer review in days, not weeks
- +Writers spend time on judgment, narrative, and review
- +Every claim resolves to a file, page, and passage on click
- +Citation graph keeps cross-section data consistent automatically
- +Append-only ledger ships embedded in the .docx
Common questions on AI-assisted CSR writing.
What is an AI CSR writing tool?+
An AI CSR writing tool generates first drafts of clinical study reports from the underlying trial inputs — protocol, statistical analysis plan, and tables/figures/listings package — and writes them into the team's existing CSR template. Asthra is an AI CSR writing tool built specifically for ICH E3 structure, with sentence-level provenance back to source files and an audit ledger embedded in the .docx.
How long does it take Asthra to write a CSR?+
First draft of all 38 sections in roughly 3–6 hours of agent runtime — typically an overnight "walk-away" run. Writer review and refinement then takes days rather than weeks. End-to-end, pilot teams have compressed CSR cycle time from 8–12 weeks of manual authoring to days for a first reviewable draft.
Does Asthra follow ICH E3 structure?+
Yes. ICH E3 (Structure and Content of Clinical Study Reports) is the canonical structure Asthra writes to. The agent encodes E3 section ordering, expected content per section, and the cross-references between sections (methods → analyses → results → discussion). Your house template is preserved — section numbering, headings, table-of-contents structure, and styles.
What inputs does Asthra need to draft a CSR?+
The same source set your writers already use: the trial protocol (with amendments), statistical analysis plan, the TFL package (tables, figures, listings), the investigator brochure for background context, and your CSR template. Optionally, prior CSRs as style references. No new system of record, no data migration.
How does Asthra prevent hallucinations in a CSR?+
Two layers. First, every generated sentence is bound to a retrieved passage from your approved source set — closed-system retrieval, no fallback to model memory or the open internet. Second, an end-of-run QC pass checks cross-references, statistical-claim binding, defined-term ordering, citation density, gap detection, and hyperlink resolution before the draft is handed back. Missing data is surfaced as explicit gap flags, not papered over.
Where does the writer actually do the work?+
Inside Microsoft Word. The Asthra add-in lives in the Word task pane; the draft lands as a normal .docx with citations and the QC report attached. Writers review with track changes, chat with Asthra in the task pane to refine sections or swap sources, and approve. No new authoring environment.
Asthra writes across the regulatory document set.
Protocol authoring →
ICH E6(R3)-aligned protocols from synopsis + investigator brochure.
PSUR / PBRER →
Aggregate safety reports from line listings, exposure, and prior PSURs.
DSUR automation →
ICH E2F development safety update reports from study-level safety data. On the near-term roadmap.
Investigator brochure →
IB drafts from nonclinical, clinical, and prior-IB content.
Clinical evaluation reports →
MDR-aligned CERs from literature, equivalence, and PMS data.
CMC (Module 3) →
Module 3 narratives from BMRs, CoAs, methods, and stability data.
Pilot Asthra
on a real CSR.
30-day pilot. Bring one trial. We'll match Asthra's draft against your existing process — section by section.