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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

Convient pour : 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.

Est-ce pour vous ?

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.

Première étape dès aujourd'hui

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.

Comment procéder

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

Modèles à copier

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Analyse

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Plan the rollout

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Inclus dans la formation

Le mode d'emploi complet

6 étapes, avec l'explication de ce qu'il faut faire exactement
3 modèles éprouvés à copier dans votre propre IA
Une mise en œuvre sûre : données, vérification, décision, information
Pièges, effort nécessaire et comment reconnaître le succès

Avec la formation, les 430 modes d'emploi vous sont ouverts pendant toute la durée de votre accès.

Voir la formationPaiement unique par personne, sans reconduction

Même démarche, autres cas d'usage

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CP-03 · État du droit 08.10.2026