All clinical investigations begin with the development of a clinical study protocol written by a multidisciplinary team and coordinated by the medical writer. Lean regulatory writing processes and tools help streamline complex document development, including protocols or other submissions to regulatory authorities and ethics committees.

In this whitepaper, we explore how these valuable tools, including software, templates and collaborative work processes, can provide practical solutions to common challenges medical writers face.

Topics include:

• Typical regulatory and lean writing workflows and timelines
• Examples of innovative document development tools that enable lean writing methods, reduce timelines and improve efficiency
• Benefits of engaging collaborative writing
• Survey results completed by 75 medical writers that reveal the strategies used within and outside ICON during document preparation
• Real case scenarios from ICON illustrating the real-world benefit of lean writing processes and tools