Using Innovative Tools and Lean Writing Workflow Processes to Accelerate Regulatory Document Writing

Abstract

Lean writing workflow processes can streamline development of complex documents, including protocols and other regulatory submissions. This paper outlines standard development timelines and describes useful lean writing workflow methods and tools to reduce protocol development timelines without sacrificing document quality. We present the results of a survey completed by 75 Medical writers (MW) that reveal the strategies used during document preparation and use real case scenarios (protocol development) that illustrate how innovative tools and approaches can be efficiently used to create a lean writing workflow process. Software tools (e.g., proofreading assistance, citation manager, collaborative authoring and reviewing) were widely accepted and used during protocol development according to the MWs surveyed. Most of the surveyed writers (62%) hypothesized a reduction in production time by about 25%. Efficient collaborative work across different time zones had a marked impact on shortening timelines while maintaining production of high-quality documents. Real case scenarios were used to illustrate how innovative tools and approaches can positively impact timelines and efficiently create a lean writing workflow process regardless of therapeutic area. The real case scenarios showed that protocol development time can be decreased by about 26% without compromising the quality of the document. This shows that software tools, templates, checklists, and collaborative writing were more impactful than hypothesized by the MWs included in the survey. With clear workflow processes, roles, and responsibilities backed by innovative software applications, template guidelines, and collaborative work processes, MWs can overcome common development challenges and improve their lean regulatory writing skills.