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AI Clinical Trial Protocol Automation

How InNeed helped a clinical research organization reduce protocol review workload by 50%, save $300,000 over three years, and accelerate clinical trial operations.

AI-powered clinical trial protocol automation platform

The Challenge

A clinical research organization processes roughly 300 trialprotocols a month. Each is an 80-100 page document, and a teammust read every page, identify every required lab test, and purchaseit for the trial. Missing a single lab can cause tens of millions in delaysand erode client trust. The work was slow, manual, and high-risk.

From Custom AI Pipelines to Intelligent Document Agents

What once required multiple OCR and NLP systems can now be handled by a single Claude-powered document agent. Claude reads entire protocols, extracts lab tests with source citations, and integrates with enterprise workflows-delivering faster deployment, higher accuracy, and simpler maintenance.

What We Built (Then)

  • Custom OCR pipeline using Amazon Textract to process trial protocols.
  • Medical entity extraction powered by Amazon Comprehend Medical.
  • Custom machine learning models built and deployed with Amazon SageMaker.
  • Additional NLP processing and validation using SpaCy.
  • Automated extraction of laboratory tests from lengthy clinical trial documents.
  • Required significant model training, tuning, and ongoing maintenance.
  • Multi-component architecture with higher deployment and support complexity.

How We Build It Now — with Claude

  • Claude reads entire clinical trial protocols natively without custom OCR/NLP pipelines.
  • Context-aware reasoning identifies laboratory tests more accurately across complex documents.
  • Returns structured lab-test outputs with source-page citations for verification.
  • Uses Retrieval-Augmented Generation (RAG) to stay grounded in governed enterprise data.
  • Connects to downstream systems through the Model Context Protocol (MCP).
  • Functions as an autonomous document-processing workflow rather than a standalone extraction tool.
  • Faster implementation with significantly reduced engineering effort.
  • Easier auditing, governance, and compliance management.
  • Designed for HIPAA-aware healthcare and clinical research environments.

Outcomes Achieved

50%

Reduction in the extraction team's workload

$300K

Projected savings over three years

100%

Durable system for clinical trial information

AWS

Featured on the Healthcare & Life Sciences Main Stage

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