How a Healthcare Agency Reduced Documentation Time by 90% Using an AI CoPilot for Medical Writing

Our client is a Healthcare Services Provider. We helped them build their AI HealthTech Product.

Today, their AI is used at Fortune 500 companies, making them America’s 1000 Fastest-Growing Companies. This AI helps busy healthcare staff complete a typical 100-hour job in less than 20 hours.

Table of Contents

Client: Confidential Healthcare Content Agency

Industry: Healthcare / Medical-Legal Services

Team: AI/NLP Engineers, Regulatory Experts, Medical Writers

About the Client

A specialized medical writing agency serving pharmaceutical and clinical research clients. They wanted to build an AI Product in Healthcare based on their expertise. Their core focus is generating patient-facing documents like Informed Consent Forms (ICFs), Patient Recruitment Materials, and Clinical Trial Agreements.

They are known for balancing scientific accuracy with readability and compliance, yet faced growing pressure to scale without sacrificing quality.

The Challenge

Creating ICFs was an intensive, error-prone process:
– Manual Review: Teams had to sift through hundreds of pages of complex protocols and reports.
– Dual Audience Needs: Simplify language for patients while ensuring legal and scientific rigor.
– Regulatory Pressure: Must align with FDA and IRB requirements without compromise.
– Time & Cost: 200+ hours per ICF led to operational bottlenecks, high costs, and limited scalability.

“It was becoming impossible to keep up with demand without risking quality or missing timelines.” – Senior Medical Writer

Our Approach & Solution

We developed an AI-powered CoPilot system tailored for healthcare document generation, integrating deep domain knowledge, contextual NLP, and regulatory intelligence.

1. Deep Domain-Specific AI Training:
   – Trained on proprietary templates and style guides
   – Ingested FDA and IRB-compliant documents
   – Augmented with AI-simulated pharmaceutical samples

2. Multi-Layered Human Oversight:
   – AI generated first drafts; humans reviewed for compliance
   – Freed medical writers from repetitive tasks to focus on accuracy

3. Intelligent Language Modulation:
   – Adapted tone based on document section
   – Simplified jargon for patients without losing scientific integrity

   4. Scalability Beyond ICFs:
   – Successfully expanded to Clinical Trial Agreements, Investigator Brochures, and more

Client Testimonial

“The CoPilot transformed how we work—cutting 90% of our drafting time while elevating both quality and client satisfaction.” — Lead Regulatory Writer

Results & Impact

Tech Stack

– AI/NLP: In-house CoPilot, Transformer-based Language Models
– Compliance Data: FDA, IRB frameworks
– Deployment: Human-in-the-loop system
– Outputs: ICFs, CTAs, Investigator Brochures

FAQ

Q: Can this system adapt to our internal templates and terminology?
A: Yes, the CoPilot can be trained on your proprietary documents and writing guidelines.

Q: How is compliance maintained?
A: Human reviewers validate all AI-generated outputs against regulatory frameworks.