Robust study summaries

Robust study summaries in IUCLID, drafted from the PDF study report.

Writing a robust study summary is expert work wrapped in hours of transcription. Dossier Flow drafts the IUCLID endpoint study record from the report, your expert reviews it, and only then is it written into your dossier.

What a robust study summary has to contain

Under REACH, every key study behind an endpoint is reported in IUCLID as an endpoint study record, and for the studies that carry the conclusion that record is a robust study summary. It has to let an evaluator judge the study without reading the report: the test guideline and any deviations, GLP status, the test material, species, route and duration, the doses, the observations, the effect levels, and the applicant's summary and conclusion.

Every one of those values already exists in the study report. The expert work is deciding what the study shows. The rest is finding each value, mapping it onto IUCLID's field model, choosing the right entry from each phrase list, getting the units right, and filling the repeatable blocks for every dose group and effect level.

Why it takes hours by hand

  • Dozens of fields per record, spread across materials and methods, results and conclusions
  • Phrase lists where the report's wording has to be matched to IUCLID's controlled vocabulary
  • Repeatable blocks for each effect level, dose group or test concentration
  • Units and decimals transcribed by hand, which is exactly where the errors come from
  • One report often feeding several endpoints, an OECD 422 being the obvious case

The judgement takes minutes. The typing takes hours.

The workflow

How Dossier Flow drafts it

1. Upload and tag

Drop the PDF study report onto a substance from your own IUCLID inventory and tag it with the endpoints it covers, or let the AI propose the tags.

2. Draft against the field schema

Claude Opus reads the report against the IUCLID field schema for that endpoint and drafts the complete record as structured data. Scanned, image-only reports are transcribed by a vision model first.

3. Review and approve

The draft arrives with its authoring notes, a schema format check and its cost. Derived values are flagged for expert review. Nothing goes further without an approval.

4. Written into your IUCLID

A browser extension writes the approved record into the IUCLID tab you are logged into, field by field, and reports back what it wrote.

What stays with your expert

The regulatory judgement. Whether a study is the key study, how reliable it is, whether an effect is adverse, what the conclusion of the endpoint should be: those remain decisions for the person who signs off the dossier. The drafts are built to make that review fast, not to replace it, and an approval by a person is the only thing that releases a write.

Once the studies of a section are in, Dossier Flow can also draft the endpoint summary that rolls them up, from the records themselves, and the DNEL, DMEL and PNEC derivations per ECHA guidance R.8 and R.10, again as drafts for your toxicologist or ecotoxicologist to confirm.

Coverage and cost

  • 108 endpoints across IUCLID chapters 4, 5, 6 and 7
  • Physicochemical properties, environmental fate, ecotoxicology and toxicology
  • Acute toxicity, irritation, sensitisation, repeated dose, genetic toxicity, carcinogenicity, reproduction and development
  • A genetic toxicity record drafted for 0.61 EUR of model usage, shown before you approve it
  • IUCLID 6, version 10.0.0

Try it on a study you know by heart.

Start the 7 day free trial with 2 EUR of drafting credit, no card needed, and draft the robust study summary of a report you have already summarised by hand. The comparison will tell you more than this page can.