CSR drafts in days, not months.
Asthra generates ICH E3–aligned CSR 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. 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 to QC & medical review
Final draft ships with the audit ledger embedded. QC reviewers use the same citation graph to verify 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
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.