TraceDraft · Analyse what you already have

Upload a finished document and see what it covers, what it misses and where it contradicts itself.

Upload an existing CSR, a vendor validation protocol, an SOP or a guideline and TraceDraft analyses it against the structure it should follow: a section-by-section summary, what each required section covers, what is missing, and where the text disagrees with itself. Every finding cites the uploaded document.

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Traced to sourceEvery statement

Human reviewBefore anything is approved

In short

Document analysis in Cybroscape TraceDraft reviews a document you already have, such as a finished clinical study report or a vendor protocol, against the structure it should follow. It reports what each section covers, what is missing and where the text conflicts with itself, with every finding cited to the uploaded document.

The problem

Most documents arrive finished, not as raw data

A CRO hands over a study report. A vendor sends its own validation protocol. A guideline is revised and someone has to work out what it now asks for. In each case the job is to read a long document carefully against a standard, and that is slow work that is easy to do unevenly.

How TraceDraft handles it

Read against the standard

The uploaded document is parsed by code into paragraphs, tables and headings, then compared with the blueprint it should match, for example the ICH E3 structure for a study report. The analysis lists each required section, what the document says there, and what it does not.

Draft safety narrative

Source data

1Adverse event listing · row 14
2Lab dataset · ALT value, day 15
3Protocol · section 7.2

Check the source, not the sentence

In a source-traceable clinical document, each statement links to the listing row, dataset value or protocol clause it came from, so a reviewer checks the source instead of trusting the sentence.

Cited like any draft

The analysis is held to the same rule as a drafted document: every sentence cites the passage of the uploaded document it rests on, and a sentence that cannot is removed. A reviewer can check any finding in one click.

A starting point for the next version

A document that has been analysed can be the base for a new version: upload the previous version and TraceDraft carries the parts whose sources did not change and rewrites the rest.

Deliverables

What you get

Finished documents analysed against the structure they should follow

Missing and thin sections listed before a sponsor or inspector finds them

Contradictions within the document surfaced

Every finding cited to the uploaded document

Summary

What Document Analysis delivers

Document Analysis is part of the TraceDraft platform — an AI-native, source-traceable clinical documentation system built for regulated Life Sciences. See how it fits with CSR Authoring, CTD Clinical Summaries, Safety Narratives.

document analysis AICSR review AIICH E3 conformance checkregulatory document review

Any uploaded PDF or DOCX
Checked against a blueprint such as ICH E3
Missing and thin sections listed
Every finding cited to the document

FAQ

Common questions

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What documents can TraceDraft analyse?

Any PDF or DOCX you upload, for example a finished clinical study report, a vendor validation protocol, an SOP or a regulatory guideline. It is analysed against the blueprint you choose, such as ICH E3 for a study report.

Does the analysis change the document?

No. The analysis is a separate document that cites the uploaded one. If you want a revised version, upload the original as a previous version and TraceDraft drafts a new one from it.

How is the analysis checked?

By the same checker as every draft: each sentence must cite a passage of the uploaded document, and sentences that cannot are removed before a reviewer sees the result.

Related capabilities

All capabilities

CSR Authoring

Compose Clinical Study Reports from your linked source data — AE listings, datasets, protocols — and generate the safety narrative appendix straight from the same source graph. One review workflow, one evidence pack, one traceable story from listing to submission.

Learn more about CSR Authoring CTD Clinical Summaries

Draft CTD Module 2.5 Clinical Overviews and Module 2.7 Clinical Summaries from your clinical study reports and integrated analyses. Each section carries the ICH M4E(R2) text it must satisfy, every sentence cites the study report passage or table behind it, and the benefit-risk conclusions stay with your writers.

Learn more about CTD Clinical Summaries Safety Narratives

A standard safety narrative template — Patient Identification, AE Description, Medical History, Study Drug, Clinical Course, Causality and Narrative Summary — with each section wired to the source types it needs. The final narrative slots directly into the CSR appendix.

Learn more about Safety Narratives Clinical Documentation

Project-scoped source management ingests the messy inputs — AE listings, datasets, protocols, PDFs — and turns them into the citable atoms behind every generated section. Writers see source coverage before they draft, so gaps are addressed early, not at QC.

Learn more about Clinical Documentation Human-in-the-Loop Reviews

A dedicated review queue routes generated sections to human reviewers with the source-link count in view — so reviewers validate AI output against the actual data behind it. The section status workflow keeps everyone honest about where a draft actually is.

Learn more about Human-in-the-Loop Reviews Clinical Automation

Generation, extraction and export run asynchronously so writers never wait for a spinner. Combined with the swappable AI provider, teams can automate draft production while keeping the human review gate exactly where it belongs.

Learn more about Clinical Automation