Home About us
CR&D Consulting
Medical Writing
Training Contact Imprint Legal Notice

Medical Writing
The creation of documents in the field of drug development is highly regulated by health authorities such as FDA, EMA, and national agencies. It requires the ability to understand complex science in any field and recognize when data are biased. In addition, scientific or medical data, information, and ideas are to be organized and explained in a clear and logical manner using the most appropriate ways of presentation.

We create documentation that regulatory agencies require during the clinical development from first in human to market approval of investigational medicinal products. We also generate documents for the medical and scientific society that describe results effectively and clearly. In summary, we provide well-structured documents that present information precisely and make sure the documents comply with regulatory, journal, or other guidelines such as Good Publication Practice (GPP) and Consolidated Standards of Reporting Trials (CONSORT).

Regulatory Medical Writing Services:

  • Study protocol
  • Clinical study report (ICH E3)
  • Investigator's brochure (IB): clinical parts and updates
  • Patient information and informed consent
  • Clinical briefing packages for scientific advice (SA) and special protocol assessment (SPA)
  • Clinical trial authorization (CTA) and investigational new drug (IND)
  • Investigational Medicinal Product Dossier (IMPD): clinical parts
  • Common Technical Document (CTD), clinical summaries and overview
  • Pediatric Investigational Plan (PIP)
Scientific Writing and Editing Services:
  • Original articles / manuscripts
  • Reviews
  • Case studies
  • Letter to the editor
  • Data presentation for medical conferences: abstracts, posters, presentations
  • Literature search, reviews and summaries
"Easy reading is damn hard writing."
                          Alexander Pope (1688-1744)

© Glasschroeder, 2018, all rights reserved Dr. rer. nat. Birgit Glasschröder