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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

Contact us by mentioning your specific requirements in the form. We extremely value your time and dedication, we will reach out to you at the earliest possible.









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