MEDICAL WRITING

CRETA’s offer to our customers extends well beyond conventional medical writing. Our approach – targeted medical writing – covers the scientific synopsis of results and data, proposes a medical interpretation and delivers a concise set of key messages. In addition, we support you to bridge information gaps in order to support a smooth project flow and a versatile document output.

CRETA has decades of scientific and writing experience in academia and the pharmaceutical industry. Through continuous training and education in medical writing we ensure the high standard of our work (e.g. medical writing courses in drug development at EMWA).

PORTFOLIO

REGULATORY AND CLINICAL RESEARCH DOCUMENTS

» Research proposals
» Clinical study protocol, amendments and other study related documents
» Integrated clinical study reports (according to ICH E3)
» Investigational Medicinal Product Dossier (IMPD)
» Investigator’s Brochure (IB)
» Writing and compiling non-clinical and clinical CTD modules (Common Technical Documents)
» Clinical trial application documents (Ethics Committees, Authorities)
» Review of the statistical analysis plan (SAP)

SCIENTIFIC WRITING AND MEDICAL COMMUNICATION

» Consulting and writing of grant submissions (clinical and experimental)
» Literature search and comprehensive summary of clinical and preclinical topics (state of the art, context to your actual data, hot topics, ...)
» Scientific manuscripts based on preclinical and clinical data (abstracts, original papers, reviews and slide sets for scientific presentations)
» Editing and proofreading of documents and articles with conceptual input and quality control
» Lay summary of CSR and other medical communication for lay audiences

Please feel free to ask about other kinds of documents.

For additional information, please refer to the homepage of EMWA, the European Medical Writers Association and the professional profile at LinkedIn.

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