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 — and ships as a structured report alongside the draft. Gap flags surface where source data is missing or contradictory.
Writer review and refinement (days)
This is the longest step, and Asthra stays in it with you. Each section arrives already checked against its guidelines and FDA precedent. Work through the flags one at a time, or name the documents that hold the missing facts and run a pass over many sections, approving each proposal. Regenerate a section with steering, rewrite a highlighted paragraph, and ask the draft why it reads the way it does. Every change Asthra makes comes back as a Word tracked change you accept or reject. See the full review and refinement flow.
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, and gap detection 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?+
In Microsoft Word or the Asthra web app, with one account. The add-in lives in the Word task pane; the draft lands as a normal .docx with citations and the QC report attached. In the browser, the web app adds collaborative authoring: co-edit in real time, comment on the text, and lock a section while you work on it. Either way, writers review tracked changes, chat with Asthra to resolve flags, regenerate sections or rewrite a passage, and approve each change.
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.
“We ran Asthra AI on a Phase 3 clinical study report alongside our traditional writing process. The quality of the draft and the speed at which it was produced genuinely impressed me. It will supplement and accelerate how we work today, and over time I expect it to become part of our core writing workstream. This is where regulatory writing is heading.”
From the blog
- FDA counted its first-cycle complete responses, and the conclusion is addressed to sponsors
In September CDER published a longitudinal analysis of first-cycle complete response rates for NDAs and BLAs from FY2008 to FY2024. The headline is that rates fell from 47% to about 27%. The more useful part for anyone drafting an application is the paragraph on who is responsible for a high-quality submission, and the trend for new BLAs that runs the other way.
- Before a New Testing Method Goes into a Submission, Write Down Exactly What It Supports
In September FDA published a direct final rule replacing 'animal' with 'nonclinical' in parts of its regulations, and EMA opened a voluntary pilot for discussing data from new approach methodologies. Neither says a particular method is enough for a particular decision. That work falls to the sponsor, the CRO that developed the method and the writer who has to state the claim precisely and keep its limits attached.
- The Study Report Is in the Data Room, but Could FDA Verify the Study?
FDA said in September that it is adding foreign inspections, including more phase 1 and early-stage trials, and looking harder at foreign studies not run under an IND. For a biotech acquiring an overseas asset, or a CRO adapting an inherited study report, the question moves into diligence: where are the records behind the report, and could FDA inspect them?
- The Expedited IND Pilot Splits the IND into Pieces, and the Writing Plan Has to Follow
FDA's Expedited IND pilot lets a sponsor and a qualified research institution send IND components for review one at a time before the formal IND. Each component has to stand on its own, and whatever FDA says about the first one has to be carried through the rest. For small biotechs and CROs considering an application before 30 October, that is a staffing and contracting question as much as a scientific one.
What it costs, and how long it takes.
Clinical study report (CSR)
Outsourced figures are typical industry ranges, not quotes. How we estimate them.
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.