Recently, Venn Life Sciences was responsible for the reporting of a first-in-human trial while simultaneously preparing several documents necessary for the opening of an
investigational new drug (IND) application for a biotech company. These documents included the investigator’s brochure and the clinical modules of the CTD. In doing so, the medical writing team had to assure consistency and alignment across the documents while adhering to the sponsor’s timelines. This required close collaboration with contributing authors and strict planning, as some documents could only be written once others were completed. We delivered all documents to the satisfaction of the sponsor and according to the requested timelines, and the IND was submitted as planned.