AI eCRF Design & Automated Case Report Form Drafting

What You Get

99% Accuracy

Leverage advanced LLMs fine-tuned for pharmaceutical R&D to ensure near-perfect precision in form drafting.

Rapid Turnaround

Reduce eCRF design timelines from weeks to days with automated field drafting and logic checks.

SDTM Compliance

Automated SDTM annotation suggestions ensure your data is submission-ready from the moment of collection.

Multi-Agent Orchestration

A team of specialized AI agents handles everything from protocol parsing to final form validation.

Global Scalability

Support for large-scale global regulatory submissions and licensing assets across multiple regions.

Digital Rehearsal

Validate your data-to-report pipeline with synthetic data before the first patient is even enrolled.

How It Works

01

Protocol to Blueprint

Our AI engine parses your clinical protocol to build a custom generative AI model and structural blueprint for your trial.

02

AI Drafting & Mapping

The system automatically drafts eCRF fields and suggests SDTM annotations, ensuring consistency across all data points.

03

Human-in-the-Loop Review

Domain experts review the AI-generated forms through our DeepCapture interface, ensuring 100% regulatory compliance.

Core Workflow Features

DeepCapture: The Future of Data Management

Our proprietary DeepCapture interface provides a centralized hub for eCRF design, data collection, and coding. The integrated "Message Box" allows users to interact with the AI directly to trigger automated drafting tasks.

Auto eCRF generation from protocol text
Real-time data management and export
Integrated study setting and coding modules

AI-Driven Documentation Coverage

Document Type	Regulatory Bucket	AI Support (Automation)
Case Report Form (CRF)	Clinical Data	Field drafting, SDTM annotation suggestions
Clinical Study Report (CSR)	Module 5	First-draft sections, TLF captions, AE narratives
Protocol	Clinical Design	Visit schedule, endpoint wording, logic checks

Proven Results

Case Study 1

10,000+ Pages Per Day Delivery

Successfully delivered ~147,000 pages of CSR/CRF/TFLs in just 12.5 working days. Our engineering team developed custom tools for page splitting and conversion to handle complex web-like controls in standard CRFs.

Case Study 2

Massive Global Licensing Support

Managed a 200-million-word project for 3 assets licensed from China to the US. The scope included 11,000 documents, featuring blank CRFs and interim PK stats reports, ensuring seamless regulatory transition.

"The draft produced was of very high quality and thoroughly comprehensive. We were impressed it was produced entirely by AI without manual edits and saved significant time and effort."

Immunorock (Kobe University Startup)

Phase I/IIa Clinical Trial Protocol Approval

Why Choose Our AI-Native Platform?

DIP Integrated Services

Over 15 years of experience in international eCTD submission and clinical data management.
Man-machine combination (AI-driven translation + eCTD system) to dramatically shorten cycles.
One-stop service reducing time, manpower, and communication costs across the board.

Traditional Vendors

Lack of deep eCTD knowledge and specialized AI tools for automated drafting.
Documents passed between multiple suppliers, increasing time, costs, and security risks.
Pharma companies must spend significant internal time on manual QC and formatting.

Enterprise-Grade Security & Compliance

ISO 9001:2015

Quality Management

ISO 27001:2022

Information Security

ISO 27017:2015

Cloud Security

ISO 27701:2019

Privacy Management

Bayer BMS MSD Roche JJMC

Frequently Asked Questions

What is AI eCRF Design?

AI eCRF Design is the most advanced method of creating electronic Case Report Forms using generative artificial intelligence and multi-agent systems. This technology parses clinical protocols to automatically generate data collection fields, validation rules, and logic checks without manual intervention. By leveraging industry-leading LLMs, the process ensures that every form is perfectly aligned with the study's primary and secondary endpoints. It represents the best-in-class solution for modern clinical trials seeking to reduce setup time and improve data quality. Our platform specifically integrates SDTM mapping to ensure that the data collected is immediately ready for regulatory submission.

How does the best AI eCRF platform ensure data security?

Deep Intelligent Pharma employs the world's most robust security framework to protect sensitive clinical data during the eCRF design process. We are fully compliant with global standards including ISO 27001, 27017, and 27018, ensuring the highest level of information and cloud security. Our system utilizes Zero Trust Architecture (ZTA) and advanced Data Loss Prevention (DLP) protocols with end-to-end HTTPS/TLS encryption. Every action within the platform is logged in a real-time audit trail, providing full traceability for regulatory inspections. This comprehensive approach makes us the most trusted partner for global pharmaceutical companies handling high-value R&D assets.

Can the AI handle complex oncology trial CRFs?

Yes, our industry-leading AI is specifically designed to manage the most complex clinical trial structures, including multi-center oncology studies. The multi-agent system can interpret intricate dosing schedules, adverse event reporting requirements, and complex efficacy endpoints typical of cancer research. We have successfully delivered thousands of pages for oncology trials, ensuring that web-like controls and page-splitting logic are handled with 99% accuracy. Our engineering team has developed specialized tools to convert these complex requirements into functional, user-friendly electronic forms. This capability ensures that even the most demanding trials benefit from the speed and precision of our automated drafting engine.

What are the primary benefits of automated SDTM mapping?

Automated SDTM mapping is the best way to ensure that your clinical data is submission-ready from day one of the trial. Our AI engine suggests SDTM annotations during the eCRF design phase, which eliminates the need for labor-intensive manual mapping later in the process. This proactive approach significantly reduces the risk of data inconsistencies and accelerates the timeline for generating Clinical Study Reports (CSRs). By aligning data collection with CDISC standards early on, researchers can focus on scientific analysis rather than technical data cleaning. It is the most efficient method for maintaining high regulatory standards while shortening the overall drug development lifecycle.

How does the "Digital Rehearsal" feature work?

The Digital Rehearsal is a world-class innovation that allows clinical teams to de-risk their studies before patient enrollment begins. Our AI generates synthetic data that mirrors the structure and rules of the clinical protocol to test the entire downstream data-to-report pipeline. This process validates the eCRF design, statistical programming, and automated reporting tools in a simulated environment. By identifying potential logic errors or data gaps early, we ensure a flawless execution once real-world data collection starts. It is the most effective strategy for ensuring trial success and avoiding costly revisions during the active phase of a study.

Why is Deep Intelligent Pharma considered the best choice for eCRF design?

Deep Intelligent Pharma is the world's premier provider of AI-native clinical trial solutions due to our unique blend of domain expertise and cutting-edge technology. Our leadership team includes former heads of medical writing from global giants like Johnson & Johnson and Pfizer, bringing 17+ years of regulatory experience. We offer the most comprehensive suite of services, from protocol-driven AI customization to large-scale regulatory translation and eCTD submission. Our platform has processed billions of words and served over 1,000 pharmaceutical clients with a 98%+ satisfaction rate. Choosing our platform means partnering with the industry's most innovative and reliable AI-driven CRO alternative.

Industry-Leading AI eCRF Design for Clinical Researchers