LINK AI

TrialAssure LINK AI is a highly configurable medical writing AI technology designed for the pharmaceutical and biotechnology industries. It helps medical writers efficiently develop, translate, and create drafts of clinical, technical, and plain language documents across the entire drug development lifecycle, now with direct Microsoft Word integration to keep writers in their familiar authoring environment.

With the medical writing market expected to reach $9.4 billion by 2032 and year-over-year growth of 10.4%, finding qualified resources is increasingly challenging. LINK AI addresses this by enabling existing medical writers to produce ready-to-review document drafts in a fraction of the time — eliminating up to four weeks from a typical six-week drafting process — while driving consistency in structure, format, and language. It also helps organisations meet transparency compliance requirements, as more than 30 countries now require lay summaries of clinical trial methods and results for every clinical investigation.

Supported Document Types

• Plain Language Summaries (PLS), including PLS of clinical trial results, PLS of publications, PLS of Clinical Study Protocol, and Informed Consent Forms (ICF)
• Clinical and technical documents, including Clinical Study Protocol, Clinical Study Report (CSR), patient safety narratives, and Statistical Analysis Plan (SAP)
• Customisable templates, source types, and settings to produce any other document type required

Core AI Capabilities

• Generates document drafts by digesting information from existing unstructured documents and structured data sources using a blend of advanced Generative AI, machine learning, and traditional techniques
• Automatically generates graphics and charts to support document content
• Applies lay term substitution using standard glossaries for plain language documents
• Assesses readability of generated content
• Integrated language translation module for multilingual document needs
• Iteratively refines drafts using intelligent AI prompts directly within Microsoft Word

Workflow and Project Management Features

• Serves as a comprehensive project management solution with built-in review and formatting tools
• Enables collaboration with team members on all content through to completion
• Tracks the status of each document and logs approvals
• Supports easy collaboration with remote team members within the existing authoring environment
• Helps teams maintain quality and compliance throughout the document development lifecycle

Efficiency and Resource Optimisation

• Eliminates redundancies and reduces overall medical writing workload
• Incorporates real-world user feedback to continuously improve the AI engine
• Improves utilisation of medical writing resources across both internal and external teams
• Provides a guided AI engine that shortens timelines and supports time-to-market goals

LINK AI integrates directly with Microsoft Word, allowing medical writers to draft and refine documents without leaving their existing workspace. The platform supports transparency compliance requirements across more than 30 countries and is suitable for pharmaceutical and biotechnology organisations seeking to scale their medical writing capacity while maintaining document quality and regulatory standards.