Document Authoring

Faro's Document Authoring solution is an AI-powered protocol drafting platform designed for Medical Writers and clinical operations teams in the life sciences industry. By combining intelligent text generation with structured content libraries and built-in compliance guidance, Faro dramatically accelerates the process of producing high-quality, consistent clinical study protocols — reducing what traditionally takes weeks to a matter of minutes.

The platform operates directly within Microsoft Word, meaning teams can adopt its capabilities without disrupting established workflows. Faro is purpose-built for sponsors seeking to reduce authoring time, minimize inconsistencies across studies, and maintain regulatory alignment throughout the document lifecycle.

Core Authoring Capabilities

• AI-based text generation: Automatically converts digital study designs into high-quality protocol drafts, significantly compressing the drafting timeline.
• Reusable content libraries: Access pre-approved content blocks tagged and organized by type, enabling Medical Writers to draft faster while remaining compliant.
• Microsoft Word integration: All authoring, review, and reuse functionality is available directly within Microsoft Word, preserving familiar working environments.
• Reference document upload: Existing clinical documentation can be uploaded to inform and guide AI content generation, ensuring outputs are contextually relevant.

Review and Compliance Features

• Out-of-the-box Checklist functionality: Provides structured review guidance to ensure consistency and accuracy across the entire document.
• Sponsor-specific Playbooks: Configurable review frameworks that enforce organizational best practices and regulatory requirements tailored to each sponsor.
• Built-in AI Review: Configurable Pathways guide users toward regulatory precedent and internal best practices throughout the authoring process.
• Regulatory alignment: Templates can be aligned to ICH M11 standards, or sponsors can bring their own custom templates.

Content Library Management

• Assisted library configuration: Faro can help sponsors configure and populate their content libraries to get started quickly.
• Self-serve content creation: Teams can independently create unlimited content blocks, organizing and tagging them by type for ease of retrieval and reuse.
• Pre-approved content reuse: Drawing from structured libraries ensures that drafted content meets compliance standards from the outset.

Efficiency and Time Savings

• Faro's Document Authoring solution can save up to 2 weeks of writing time for a typical Phase III study.
• Reduces inconsistencies across studies by standardizing content through reusable libraries and configurable templates.
• Streamlines effort across every study by integrating drafting, review, and compliance guidance into a single, cohesive workflow.

Faro's Document Authoring module is part of a broader platform that also includes Study Design optimization and Workflow Automation capabilities — covering areas such as EDC build, site budgets, and vendor data transfer specifications — enabling life sciences organizations to move from document-driven to data-driven clinical operations.