The New Frontier of Lean Authoring: Human-Centered Design in Regulatory Writing

In the evolving landscape of regulatory writing, it has become clear that creating clear and compliant documents is no longer enough. Building off the principles of lean authoring, regulatory writers must now consider holistically the experience of those who will review the documents. This is where human-centered design (HCD) principles, traditionally used in product and…

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The Crucial Role of Accessibility in Medical Writing Authoring Tools: Building Inclusivity from the Design Phase

In the race to bring software solutions to market, many software vendors face the challenge of balancing functionality, speed, and user experience. Often, accessibility can become an afterthought—not by intention, but due to the fast-paced nature of development. However, ensuring that authoring tools are accessible from the start offers immense benefits for all users, especially…

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Why Subject Matter Experts Are Essential in Creating AI-Enabled Medical Writing Tools

AgileWriter™ is an AI tool designed specifically for medical writing, developed by experts in the field to meet the precise needs of clinical documentation. Importance of Subject Matter Experts: Involving subject matter experts (SMEs) in the creation of AI tools for medical writing ensures the tool is practical and meets user needs, avoiding misalignment and inefficiencies. Consequences of Excluding SMEs: Without direct input from medical writers, AI tools may focus on flashy features rather than essential functions, leading to misaligned priorities, extra user steps, and lost productivity. Benefits of AgileWriter™ are developed by medical writing leaders, integrates seamlessly into workflows, reducing guesswork and enhancing writing efficiency.

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