Let’s Talk AI
  1. Home
  3. Case Study
  5. Automated eCRF Specification Generation System for Clinical Trials

Automated eCRF Specification Generation System for Clinical Trials

We developed a document intelligence system that automates the creation of Electronic Case Report Form (eCRF) specifications for clinical trials.
 The platform extracts structured data, validation rules, and dependencies directly from complex study documents , significantly reducing the time, cost, and human effort involved in eCRF preparation for pharmaceutical and research organizations.

// 👇 Auto focus active item in scrollable nav // On scroll // Smooth scroll on click top: target.offsetTop - 100, // adjust offset for sticky headers

Tags

Blog News Uncategorized

Summary :

We have built an AI-powered automation system that processes clinical trial documents to generate complete eCRF specifications in standardized, machine-readable formats. By combining OCR, NLP, and graph-based data modeling, the system extracts study procedures, edit checks, and validation logic from unstructured PDFs, Word files, and rule sheets. It ensures regulatory compliance, improves data consistency, and enables faster study setup for clinical research teams.

Problem

Problem

Objectives

  • Automate eCRF Creation

    Convert trial protocols and rule documents into structured eCRF specifications.

  • Ensure Regulatory Compliance

    Align outputs with CDASH and MedDRA standards.

  • Extract and Standardize Data

    Transform unstructured documents into clean, machine-readable formats.

  • Model Rule Relationships

    Use graph databases to link edit checks, data fields, and dependencies.

  • Improve Speed and Accuracy

    Reduce manual workload while ensuring consistent, validated outputs.

Challenges

  • Handling diverse document formats (PDF, Word, Excel, scanned images).
  • Extracting complex validation rules and interdependencies.
  • Managing medical terminology and hierarchical data standards.
  • Balancing automation with accuracy for compliance-critical outputs.
  • Visualizing rule relationships across hundreds of fields and entities.

Solution

We developed an AI-based eCRF automation system that transforms unstructured trial documentation into standardized, regulatory-compliant specifications.
Using Mistral OCR and Google Gemini models, the platform extracts data from multi-format documents, detects rule logic, and organizes it into structured JSON and Excel outputs.
A graph database (Neo4j) models dependencies between fields and rules, while Milvus vector search enables intelligent document retrieval and comparison.
 The Streamlit interface allows users to upload documents, view extracted structures, visualize rule networks, and export final eCRF specs instantly.

Technologies

Architecture

Document Upload & Processing
PDFs, DOCX, and rule files uploaded through Streamlit.
Text Extraction
OCR and text models extract study procedures, rules, and field data.
Data Structuring
LLMs standardize extracted content into CDASH-compliant formats.
Relationship Mapping
Graph database models dependencies and edit-check relationships.
Output Generation
eCRF specifications exported as Excel, JSON, and visual graph reports.

Results & Impact

Automated generation of eCRF specifications from unstructured clinical documents

Reduced manual processing time by 85%, improving trial setup efficiency

Modeled complex validation rule relationships for better data integrity

Improved compliance and consistency with CDASH and MedDRA standards

Enabled faster, error-free eCRF preparation for clinical research teams

Problem solved. Brainy Neurals accelerates AI
development for everyone

Let’s transform your business with custom AI solutions — from
ideation to deployment.

Explore this solution
Here’s What Clients Say About Working With Us

Let’s transform your business with custom AI solutions — from ideation to deployment.

What Our Clients are Saying

We’ve partnered with global businesses to deliver AI solutions that unlock growth, efficiency, and innovation.

Santiago Correal Mantilla
Santiago Correal Mantilla
Founder, Nexx AI
“Brainy Neurals is an incredibly skilled and adaptable team. Whether I come with a full plan or just a vision, they always deliver beyond expectations. “
Cornelius
Cornelius
Founder, Shatterpoint
“Brainy Neurals' AI algorithms have provided us with invaluable insights that have transformed our decision-making process. Their dedication to innovation and exceptional customer service make them the go-to partner for AI solutions.“
Vineet
Vineet
Gauss Moto Inc
“Working with Brainy Neurals has been a game-changer for our organization. Their expertise in AI technology and their ability to tailor solutions to our specific needs have helped us stay ahead of the competition.“
Vlad Tudor
Vlad Tudor
Founder, Sapio AI
“My experience with this RAG project was great. The team built a system that delivers accurate, context-aware responses. From summarizing documents to answering complex queries and improving knowledge retrieval, their efficient implementation ensured smooth and reliable performance.“
Dr. Alper Altinok
Dr. Alper Altinok
CEO, Bugmapper
“Working with Brainy Neurals has been a remarkable experience for our greenhouse farms. Their AI-powered chatbot provides real-time insights that have completely transformed our insect monitoring process. Their expertise and innovative approach have truly made a difference!“
Helen Yang
Helen Yang
Founder, Andes Risk
“Brainy Neurals has done an outstanding job in developing an AI-powered chatbot that streamlines investor profiling. By leveraging advanced data analysis and LLM integration, they’ve made it effortless to understand each client’s risk tolerance and investment behavior. Truly impressive work!“
Ketan Dayma
Ketan Dayma
CEO, Unidoc
“Brainy Neurals' OCR-based system has made medical report processing much easier. It accurately extracts patient data and summarizes key information, saving us a lot of time and effort. The automation works smoothly and has improved efficiency in handling reports“
Fred Fishback
Fred Fishback
“With strong expertise in GenAI, image-to-video generation, lip sync, and speech synthesis, the team has created AI avatars that feel remarkably lifelike. Their innovation makes interactions more engaging and dynamic, setting a new standard in AI-driven experiences. “
Amit Yadav
Amit Yadav
Founder, Gemperts India Pvt Ltd
“My experience with this project showcased the team’s strong expertise in computer vision and depth estimation. They provided a complete solution, including the app and backend, ensuring seamless integration and high performance. “
Billy Brush
Billy Brush
Founder, Darkhorse.AI
“The team's attention to detail in data annotation was evident throughout the project. They provided accurately labeled datasets with consistency, ensuring smooth AI model training. Their structured approach made the entire process efficient and reliable. “
Ready to turn your AI
Ideas into impact?
We’re here to help.
Let’s Connect to help you and your team
Please enable JavaScript in your browser to complete this form.

1109,11th Floor, The Orion, SG Highway, Gota, Ahmedabad, 382481

Privacy & Policy
Site Map
Email:
Customer Inquiries: hello@brainyneurals.com

Jobs:
humans@brainyneurals.com
Connect with us
Instagram
Services
Rapid POC & MVPs
Vision AI
Generative AI
Edge AI
Conversational Intelligence
Data Engineering
AI Product Design
Data Annotation
AI Impact
Healthcare & Life Sciences
Financial Services & Insurance
Manufacturing & Industry
Transportation & Logistics
Other Industries →
Upwork logo with hand holding pink envelope
Company
About us
Contact us
Five red stars rating by Clutch
Made with ❤️ in India and Serving Worldwide.
Copyright © 2025 Brainy Neurals. All Rights Reserved

USA | UK | AUSTRALIA | SINGAPORE | UAE | EUROPE

Instagram Youtube Facebook X-twitter
Five red stars rating by Clutch
Upwork logo with hand holding pink envelope
Services
Rapid POC & MVPs
Vision AI
Generative AI
Edge AI
Conversational Intelligence
Data Engineering
AI Product Design
Data Annotation
Resources
Case Studies
Perspectives
Industries We Serve
AI Staff Augmentation
About Brainy Neurals
About us
News
Contact us
Copyright © 2026 Brainy Neurals. All Rights Reserved | Privacy Policy | Sitemap
Services
Vision AI
Generative AI
Edge AI
Conversational
Intelligence
Data Engineering
AI Product Design
Data Annotation
AI Impact
Healthcare & Life Sciences
Financial Services & Insurance
Manufacturing & Industry
Transportation & Logistics
Other Industries →
Connect with us
Company
About us
Contact us
Follow Us
Instagram
Made with ❤️ in India and Serving Worldwide.
Privacy & Policy

USA | UK | AUSTRALIA | SINGAPORE | UAE | EUROPE

Copyright © 2025 Brainy Neurals. All Rights Reserved