Challenge

• Preparation of nonclinical and clinical Common Technical Document modules for an Investigational New Drug (IND) application, including an update and overhaul of the Investigator’s Brochure (IB), under expedited timelines (12 weeks; initial timelines had been 24 weeks)
• Clinical modules (Modules 2.5, 2.7.2 and 2.7.4,) and the nonclinical overview (Module 2.4) were to be written from scratch
• Nonclinical modules (Module 2.6) were pre-drafted by the end client by different authors, and lacked consistency of terminology and presentation
• The IB contained scientific literature reviews that had become redundant based on the stage of development, and an accumulation of dense data and complex textual descriptions
• Some nonclinical studies were still being finalized; data were subject to change
• The key clinical protocol was undergoing amendment while the summary and overview documents were being prepared

Approach

• New document timelines were developed with parallel preparation of summary documents, which included 2 rounds of review plus quality control (QC) cycles
• Several medical writers were assigned to the project in order to accommodate the new expedited timelines
• To ensure consistency between documents, 1 writer was designated to oversee the 3 nonclinical written summary modules and the nonclinical overview, and 1 writer was assigned to oversee the 3 clinical summary modules and clinical overview
• Discussion and agreement between writers were sought on what data could be summarized or removed from the nonclinical modules and IB
• Weekly meetings with the client took place to ensure agreement with edits and alignment on document development
• Continual communication between authors of the different nonclinical and clinical modules and IB was achieved using Microsoft Teams to boost consistency and efficiency
• Documents were drafted with placeholders for missing data to achieve the first round of review
• Missing data were incorporated ahead of the second review cycles which still involved the initial content, but with a focus on newly added information
• QC was used to confirm consistency in content between modules as well as to check data accuracy. Targeted QC was used for sections updated in response to late breaking sources

Result

• An excellent team relationship with the client, with strong mutual understanding of document interdependencies
• The IB and nonclinical summaries were re-focused and harmonized
• The nonclinical overview and clinical modules were written in a lean style to highlight key elements of the drug development, with cross references to other documents where appropriate
• All documents were thoroughly reviewed and underwent rigorous QC checks