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Case Study

Streamlining Clinical Protocol Generation with AI-Powered Medical Writing Tool

No of Users

15–20 internal clinical and medical writing professionals

Project Duration

1 month (Prototype to Demo and Feedback Integration)

About Client

Harmony Biosciences (HBS) is a biopharmaceutical company focused on innovative treatments for rare neurological conditions. Their clinical and regulatory teams are responsible for authoring and managing a variety of critical documents like protocols, CSRs, and SAPs.

Technology and Services

ASP.NET Core Web API, Angular, SQL Server, Azure OpenAI and Azure Cognitive Search, OpenXML SDK, Microsoft Add-ins, Integration with Veeva

Industries

Pharmaceutical / Life Sciences

The Medical Writing Tool presented a significant shift in our protocol preparation workflow. The AI-driven content generation, redlining, and reviewer collaboration features helped accelerate our internal document lifecycle. We look forward to scaling this across more studies.

– VP, Clinical Development & Strategy, Harmony Biosciences

60%

Time reduction in first-draft protocol creation

90%

accuracy in AI-generated content during pilot
  • Seamless collaboration between medical writers and reviewers
  • Enabled structured, auditable review trail with redline handling

Project Synopsis

The project aimed to transform HBS’s manual protocol and CSR preparation process into a smart, AI-assisted system. By leveraging prompt engineering, contextual search, and structured templates, the tool enabled faster, more consistent, and review-friendly document generation.

The Challenge

  • Time-consuming manual drafting of protocols and safety reports.
  • Repetitive population of data from multiple systems.
  • Fragmented review and collaboration between writers and reviewers.
  • Minimal reuse of structured content across studies.
  • Lack of real-time AI assistance to improve productivity.

The Solution

    • Built an AI-powered platform with smart template processing and section-wise content generation.
    • Added an integrated TOC-based Word editor with AI assistance side panel.
    • Enabled placeholder-driven data mapping from external sources (PDF, Word, APIs).
    • Allowed reviewers to redline and approve document changes collaboratively.
    • Introduced prompt refinement capabilities for writers to control AI output precision.

The Result

  • Successfully presented and validated the tool with HBS stakeholders.
  • Incorporated key feedback for enhanced user control and review experience.
  • Received HBS’s internal approval to begin using the tool in live protocol development.
  • Aligned clinical, regulatory, and medical writing teams around a common, AI-augmented workflow.

Get in touch with HexaCorp

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