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AI-Assisted CSR Drafting — Inside Microsoft Word

Generate structured first drafts of Clinical Study Reports from approved sources in 30 minutes, with full traceability and human review.

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Asthra AI automates Clinical Study Report (CSR) drafting by converting trial protocols and Tables, Figures, and Listings (TFL) into structured section drafts aligned to ICH E3 guidelines, with writer-defined provenance and full traceability — all inside Microsoft Word.

Who This Is For

Clinical & Regulatory Writers

Pharmaceutical and biotech companies managing clinical trial documentation pipelines.

CRO Delivery Teams

Contract research organizations delivering CSRs to sponsors under tight timelines and quality requirements.

The Challenge of CSR Drafting

Four critical bottlenecks that slow down CSR delivery

Lack of accurate, predefined templates

Writers often draft from scratch using empty templates. Inconsistent starting points across studies lead to variable quality and increased rework during QC.

Time-consuming manual effort for mapped content

Clear mapping exists between source documents and CSR sections. Yet drafting remains manual: rewriting, copy-paste operations, summarization, and interpretation are error-prone and consume 6+ weeks per study.

Manual summarization risks omitting crucial info

Non-data-driven sections (ICH sections 1–9) require careful rewriting from trial protocol. Missing study objectives, inclusion/exclusion criteria, or safety monitoring details has serious regulatory consequences.

High-volume data requires consistent interpretation

Data-driven sections require consistent interpretation of statistical outputs across multiple study objectives and endpoints. Scaling this without errors and ensuring consistency across tables is extremely labor-intensive.

How Asthra Supports CSR Drafting

From protocols and tables to structured first draft in 30 minutes

1

Click pre-configured prompts

Asthra comes with writer-validated prompts for each CSR section. No configuration needed—prompts are pre-designed during onboarding to specify exact source locations (file, section, table).

2

Content is intelligently retrieved and generated

Asthra retrieves appropriate granular content from the right source documents, interprets it, and generates narrative. For each output, provenance is automatically tracked.

3

Review provenance and citations on the fly

Writers see which source document and section was referenced. Sentence-level citations are available on demand. Writers can modify prompts or change provenance to correct any output.

4

Generate entire CSR first draft in 30 minutes

All transactions remain persistent for audit purposes. Writers edit the draft in Word as usual. Initial CSR draft ready for QC review and refinement.

The CSR Drafting Workflow

Four stages from setup to publication-ready content

1

Template Import

Import the CSR template (standard ICH, TransCelerate, or customer custom). Asthra team has pre-configured prompts and provenance rules.

2

Upload Source Documents

Upload Trial Protocol and TFL. Documents can be from your local machine or integrated from your Document Management System.

3

Generate Content

Click pre-configured prompts to generate content. Zero configuration needed. Review provenance and citations on the fly. Initial draft in 30 minutes.

4

Review & Edit

Writers edit in Word anytime. Correct provenance by selecting different source sections. All transactions persistent for auditors.

Built-In Evidence & Traceability

Maintain audit-ready documentation with every draft

Closed System Architecture

Asthra uses only source documents you provide. No access to internet. No LLM training knowledge. Complete data boundary isolation.

No Hallucination Guarantee

Granular context engineering prevents fabrication. Missing information is flagged with clear messages, never invented.

Two-Level Traceability

First level: provenance shows which source file and section was referenced. Second level: sentence-level citations with file name, page number, and exact text snippet.

Writer-Controlled Provenance

Writers can modify prompts or change provenance sources at any time to regenerate content with different inputs. Full control remains with the writing team.

What Asthra Can Help With

Asthra Excels At

  • •Content retrieval and generation from sources
  • •Summarization and rewriting
  • •Table and figure interpretation
  • •Simple calculations
  • •Compiling information into consistent narratives

Out of Scope

  • •Complex statistical calculations
  • •Retrieving from or manipulating very large tables
  • •Clinical judgment or medical interpretation

CSR-Specific Questions

Asthra requires the Trial Protocol and Tables, Figures, and Listings (TFL). Additional documents like the Statistical Analysis Plan (SAP) can be included to enhance output quality and provide more complete context.
Asthra supports standard ICH E3 templates, TransCelerate CSR templates, and customer-specific custom templates. Templates are onboarded and configured by the Asthra team during the initial setup phase.
Approximately 30 minutes for the complete initial draft generation. This covers both non-data-driven sections (1–9) derived from the trial protocol and data-driven sections (10+) interpreted from TFL statistical outputs.
Yes, Asthra generates content for all CSR sections. Non-data-driven sections (1–9) are generated from the protocol text, while data-driven sections (10+) are generated from statistical tables and figures with consistent narrative interpretation.
Asthra retrieves relevant statistical tables and figures, analyzes them in context, and generates consistent narrative interpretations aligned to clinical and statistical standards. Writers review and refine interpretations with full visibility into source data.
Asthra explicitly flags gaps with a clear message rather than fabricating content. Writers can then provide additional source documents, manually draft the missing section, or modify the prompt to request different content.

See Asthra Draft a CSR

Request a personalized demo to see how Asthra generates your first CSR draft from trial protocol and TFL.

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