Medical Writing & Translations
Our team of experienced medical scientists can write all documents for your study, clinical evaluation, scientific publications and marketing authorization applications: in English or French.
We write all your study documents, from design to reporting, including synopses, protocols, case-report forms (CRFs), information and consent forms, study reports, as well as documents for regulatory applications.
We are thoroughly familiar with all applicable international standards and with the European regulatory framework and experienced in the whole study process. This allows us to anticipate difficulties and avoid pitfalls.
Marketing authorization applications
We prepare your Common Technical Documents (CTD), whether those are based on original research or on bibliographic review. We are especially experienced with sections 2.5 (Clinical overview), 2.7 (Clinical summary) and Module 5 (Clinical study reports).
We also prepare simplified applications, for instance for generic drugs, amendments of an existing authorization, and summaries of product characteristics.
Our medical writers being bilingual, we are able to write any document either in English or French, translate your documents ENG-FR or FR-ENG. For most of the remaining European languages, we are able to proofread the translations made by your or our preferred translation vendor, to ensure the best quality of all documents.