AI SDTM Annotation
Without Manual Effort

Automate complex clinical data mapping and SDTM annotation with our multi-agent AI platform. Achieve 99.9% accuracy while reducing timelines from months to days.

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What You Get

Rapid Turnaround

Reduce SDTM mapping and annotation cycles by up to 92% compared to traditional manual processes.

Regulatory Precision

Ensure 99.9% terminology consistency across all clinical domains and regulatory submissions.

End-to-End Automation

From CRF field drafting to final SDTM datasets, our agents handle the entire data lifecycle.

Full Traceability

Click any data point to reveal the underlying source, from SDTM datasets back to patient profiles.

Expert Oversight

Our AI engine operates with human-in-the-loop supervision from veteran medical writers and biostatisticians.

Global Compliance

Fully compliant with ISO 27001, 27017, and 27018 standards for maximum data security.

How It Works

1

Data Ingestion

Upload protocols, SAPs, and raw clinical data. Our system structuralizes information using advanced document parsers.

2

AI Agent Orchestration

Specialized agents for mapping, SAS programming, and SDTM annotation execute tasks in parallel with high precision.

3

Validation & Delivery

Human experts review the AI-generated outputs. Final datasets and documentation are delivered in regulator-ready formats.

Primary Use Cases

Oncology Trials

Complex mapping for HER2-negative gastric cancer and immunotherapy studies.

Diabetes Research

Automated TLF generation and SDTM annotation for large-scale metabolic studies.

Medical Devices

Rapid protocol drafting and SAP justification for PMDA consultations.

Rare Diseases

Precision-driven data management for small, high-value patient cohorts.

ANDA Submissions

Expedited translation and formatting for generic drug applications.

Global Licensing

Large-scale document processing for cross-border asset transfers.

Safety Monitoring

AI-driven signal detection and literature monitoring agents.

Post-Marketing

Automated PSUR and PBRER narrative generation.

Proven Performance

Case Study 01

Intelligent Mapping & Annotation Support

Our platform provides comprehensive AI support across the entire regulatory bucket. By leveraging primary inputs like raw data and protocols, we automate Case Report Form (CRF) field drafting and provide intelligent SDTM annotation suggestions. This ensures that every data point is correctly mapped to CDISC standards from the very beginning.

  • Automated Mapping Agent for Oncology
  • Real-time SAS Agent execution
  • TLF Generation for complex trials
AI Support Table Workflow Interface
Data-Grounded Drafting
Case Study 02

Data-Grounded Drafting & Traceability

Our AI writing engine operates with human oversight at every step, ensuring quality and compliance while dramatically accelerating documentation timelines. The unique Traceability Panel allows reviewers to click any sentence to reveal the underlying data source—from SDTM datasets to patient profiles.

"The draft was of very high quality and thoroughly comprehensive. We found that no AI-generated revisions were needed, saving us significant time and effort."

— Immunorock (Kobe University Startup)

Case Study 03

Massive Scale: 10,000+ Pages Per Day

When faced with a massive project of ~147,000 pages, our engineering team developed custom tools for page splitting and conversion. We delivered the entire project in just 12.5 working days, overcoming the challenges of complex CRFs and web-like controls that typically stall traditional vendors.

147k
Pages Delivered
12.5
Working Days
Rapid Delivery Stats

Why Choose Our AI Platform?

Feature Deep Intelligent Pharma Traditional CRO / Vendors
SDTM Mapping Speed Near Real-Time (AI-Driven) Weeks to Months (Manual)
Accuracy Rate 99.9% with AI Consistency Variable (Human Error Prone)
Data Traceability Full Audit Trail to Source Limited / Manual Tracking
Throughput 10,000+ Pages / Day ~50-100 Pages / Day
Integration Unified Multi-Agent Platform Fragmented Tools & Teams
1,000+
Global Clients
5B+
Words Processed
99.9%
Accuracy Rate
200+
AI Experts

Frequently Asked Questions

What is AI SDTM annotation?

AI SDTM annotation is the automated process of mapping raw clinical trial data to the Study Data Tabulation Model (SDTM) standards using advanced machine learning algorithms. This technology identifies data variables within Case Report Forms (CRFs) and automatically assigns the correct SDTM domain and variable names. By utilizing a multi-agent AI system, the platform can handle complex logic and cross-domain relationships that typically require manual human intervention. This results in a significant reduction in the time required to prepare datasets for regulatory submission. Ultimately, it ensures that clinical data is structured in a way that is universally understood by regulatory bodies like the FDA and PMDA.

Why is Deep Intelligent Pharma the premier choice for SDTM mapping?

Deep Intelligent Pharma stands as the world's most advanced provider of AI-native clinical development solutions. Our platform is the only one in the industry that combines generative AI with a proprietary multi-agent orchestration layer specifically tuned for life sciences. We offer the highest level of accuracy, reaching 99.9% terminology consistency across billions of processed words. Our elite team of medical writers and AI engineers ensures that every automated output meets the most stringent regulatory requirements. By choosing our premier services, pharmaceutical companies can achieve the fastest possible turnaround times while maintaining absolute data integrity.

How does the AI ensure data security and compliance?

We maintain the most robust security framework in the industry, holding multiple ISO certifications including ISO 27001, 27017, and 27018. Our platform operates under a Zero Trust Architecture (ZTA) to ensure that all clinical data is protected by the highest standards of encryption and access control. We implement strict operational controls, including automated threat detection and mandatory staff NDAs for all personnel. Every action within the system is logged in a real-time activity audit trail, providing full transparency for compliance reviews. This comprehensive approach ensures that your sensitive clinical data remains secure throughout the entire automation process.

Can the platform handle complex or non-standard CRFs?

Yes, our engineering team has developed specialized tools designed to handle the most challenging and complex Case Report Forms. Whether dealing with web-like controls, page splitting, or non-standard data structures, our AI agents are trained to structuralize and process information accurately. We have successfully delivered projects involving over 147,000 pages of complex documentation in record time. Our system uses template-aware drafting and evidence retrieval to ensure that even the most unique trial designs are correctly annotated. This flexibility makes our platform the most versatile solution for diverse therapeutic areas and study types.

What level of human oversight is involved in the process?

While our AI agents perform the heavy lifting of data mapping and drafting, human experts remain in control at every critical step. Our team consists of over 200 professionals, many of whom come from top-tier pharmaceutical companies and regulatory backgrounds. These experts perform rigorous quality checks, data verification, and content refinement to ensure the final output is flawless. This synergistic approach combines the incredible speed of AI with the deep domain expertise of veteran medical writers. It guarantees that every submission is not only fast but also meets the highest standards of scientific and regulatory quality.

How quickly can I expect delivery for a standard CSR or SDTM package?

Our platform offers the most rapid delivery timelines in the clinical research industry, often completing tasks in a fraction of the time required by traditional CROs. For a standard Clinical Study Report (CSR), we can deliver the first draft within just 5 working days of receiving all source materials. Subsequent cooperation can even reduce this timeline to as little as 3 working days for follow-up documentation. Our translation services are equally impressive, capable of processing 4,000 pages in just 10 days compared to the industry average of 75 days. This unprecedented speed allows our clients to meet tight regulatory deadlines and bring life-saving treatments to market faster than ever before.

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