AIClinica:
Transform Clinical Data with AI

Revolutionize CDISC-compliant SDTM dataset creation with intelligent automation, reducing manual effort by up to 70% while ensuring regulatory compliance.

Industry Challenges We Solve

🔄 Manual Mapping

Raw data fields require manual mapping to SDTM variables and domains, creating inconsistencies across teams and consuming valuable time.

⚠️ Inconsistent Derivations

Variable derivations like VISITNUM, EPOCH, and date imputation vary between programmers, leading to quality issues and compliance risks.

 
🐛 Data Quality Errors

Implausible values such as negative ages or invalid dates often slip through initial validation, causing downstream issues.

💻 High Programming Overhead

Extensive SAS coding is required for transformations, with limited reusability of logic across studies and organizations.

AI-Powered Solutions  

🧠 Smart Mapping Assistant

Technology: BioBERT & SciSpacy NLP models

Outcome: Reduces manual mapping by 50-70% through intelligent semantic analysis of raw datasets and automated SDTM variable suggestions.

🔧 Auto-Derivation Engine

Technology: Hybrid rule-based + ML system

Outcome: Learns derivation logic for VISITNUM, EPOCH, DY fields, ensuring faster processing with full traceability and reduced human error.

🧹 ML Data Cleaning

Technology: XGBoost & Anomaly Detection

Outcome: Automatically flags implausible values and patterns, providing intelligent suggestions for data correction.

✅ AI-Enhanced Validation

Technology: Classification models trained on Pinnacle21 outputs

Outcome: Prioritizes critical errors, auto-suggests fixes, and accelerates issue triage with intelligent validation.

AI-Powered Solutions  

📉
40% Time Reduction

Dramatically faster dataset creation and issue resolution through intelligent automation

🎯
Enhanced Quality

Fewer manual errors and consistent mappings across all studies and teams

📚
Knowledge Democratization

AI tools make expert logic and CDISC standards accessible to all team members

🧠
Built-in Learning

Interactive bots help users understand errors and learn CDISC compliance principles

Who Benefits from AIClinica

🏢 Large Pharma

Streamline SDTM and ADaM dataset creation, reduce validation cycles, and accelerate regulatory submissions with enterprise-scale AI automation.

🤝 Contract Research Organizations

Standardize workflows across multiple sponsor trials, reduce manual programming effort, and improve consistency with intelligent automation.

🚀 Biotech Startups

Leverage AI to automate complex data transformation and validation tasks, even with limited internal data science teams.

📊 Data Service Providers

Enhance service quality and dramatically reduce turnaround times using cutting-edge intelligent automation capabilities.

The Future of Clinical Data

Our AI-driven solutions represent the next evolution in clinical data management. Future developments will expand into ADaM dataset creation, TLF generation, and automated specification creation from SAP and Protocol documents, building a fully intelligent clinical data pipeline that transforms how the industry approaches regulatory submissions.

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