Draft study reports and dossier texts from analysis tables

Pharmaceutical companies produce marketing authorisation documents and study reports from trial data

Needs setupAI Act: no extra obligationsDrafting binding documentsChemicals & pharma

Fits: Legal & compliance · Research & development

Checked analysis tables turn into first drafts of results sections for study reports and summaries in the marketing authorisation dossier more quickly. Medical writers, clinical staff and statisticians check statements instead of copying out tables.

Is this for you?

  • You regularly write study reports, clinical summaries for the dossier or responses to questions from the authorities.
  • Analysis tables and figures from statistics are available in final, quality-assured and versioned form, together with the protocol and the statistical analysis plan.
  • You can run a tool in a validated environment, and quality assurance, the regulatory affairs department and data protection are involved.
First step today

Take an invented or already published results table, e.g. adverse events by treatment group, without data on individual participants. Use the template below to have a short results section written with a source reference after every figure, and check figure by figure whether the AI has calculated, judged or added anything.

How to go about it

  1. Define the document type, requirements and responsibilities
  2. Provide final tables, the document template and in-house wording
  3. Have results sections drafted
  4. Check figures and statements against the tables and the analysis plan
  5. Sign off and submit according to the standard operating procedure
  6. Keep templates and instructions up to date

Templates to copy

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The complete guide

  • 6 steps explaining exactly what to do
  • 3 proven templates to copy into your own AI
  • Safe use: data, checking, deciding, informing
  • Pitfalls, effort and how to recognise success

With the training you get all 430 guides for as long as your access runs.

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Same approach, other use cases

13 more use cases follow the pattern “Drafting binding documents”.

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CP-03 · Legal status 08.10.2026