Quality
We never compromise on excellence.
Accelerating Drug Development with Data-Driven Biometrics & Clinical Intelligence
We offer comprehensive clinical development from EDC to NDA/BLA approval. Our intelligence platform spans multiple therapeutic areas with real-time analytics. 15+ years, 1800+ studies, 50+ successful approvals delivering faster enrollment, minimal queries, and efficient regulatory pathways.
Service Highlights
End-to-end clinical solutions powered by AI and human expertise to ensure quality, efficiency, and faster patient access to care.
Intelligence
We embrace technology to push boundaries.
Efficiency
We move quickly and deliver on time, every time.
Compassion
We care about the people behind every project.
Clinical AI Enablement Services
Industry Experience Transformation
Valuable experience from 54 successful NDA/BLAs directly converted into AI training data, ensuring model professionalism and practicality.
Dual Expertise Integration
Deep integration of biostatistics and AI technology, understanding both business and technology, avoiding "AI for AI's sake" pitfalls.
Compliance-First Approach
All solutions comply with 21 CFR Part 11, GDPR, and other regulatory requirements, eliminating compliance risks for clients.
Mature Foundation
Existing AI Dashboard system and Agent development capabilities enable rapid deployment of new services, reducing implementation risks.
Flexible Deployment
Supporting cloud, on-premise, and hybrid deployment models to meet diverse client security and cost requirements.
Intelligent Clinical Data Labeling Services
An industry-leading data labeling system powered by 15+ years of clinical trial expertise and AI technology.
Annotation standards integrated from 1,800+ projects
Intelligent processing of AE classification, medical coding, and image annotation
Fully compliant with FDA/EMA data quality requirements
Results delivered in 3-6 months with minimal investment
Clinical Research Domain Knowledge Graph
A comprehensive knowledge network built on 50+ successfully approved NDA/BLA projects, covering disease–drug–gene–endpoint relationships.
Integrates historical trial data, regulatory requirements, and best practices
Intelligent decision support for protocol design, control group selection, and endpoint prediction
Second-level retrieval with deep industry insights
RLHF - Reinforcement Learning from Human Feedback
AI continuously refined by 200+ biostatisticians and data management experts, ensuring professional-grade outputs through real-world human feedback.
Expert judgment embedded into AI, such as SAP review, data review, clinical decision-making
Optimal human-AI collaboration in high-stakes, judgment-intensive tasks
Continuously iterated on real projects to meet the highest industry standards
RAG - Retrieval-Augmented Generation System
A clinical development-specific intelligent Q&A system built on ICH guidelines, FDA/EMA requirements, and 1,800+ historical trial datasets.
Instant, accurate support for regulatory consultation and requirement interpretation
Intelligent assistance for trial documentation preparation
Massive professional knowledge base with real-time update mechanism
Continuously iterated on real projects to ensure output quality
Clinical AI Workflow Automation
End-to-end process automation covering the complete chain from EDC data cleaning and quality checks to TFL generation.
Intelligent orchestration and task scheduling across clinical data workflows
Comprehensive efficiency gains of 60-80% in clinical data processing
Seamless integration into existing data pipelines
AI Skills Components & Tools Development
Modular, plug-and-play AI function libraries for rapid development of custom clinical decision support tools — powered by 6 patented technologies and a 50-member AI R&D team.
Ready-to-deploy AI components for specific clinical trial needs
Built on deep understanding of real-world clinical business scenarios
Designed for practicality and usability, not just technology showcase
Biometrics
Advanced biometrics integrating clinical intelligence with automation to deliver submission-ready data with precision and uncompromising integrity.
Clinical Data Management
Streamline your clinical data lifecycle with our AI-enhanced EDC&CDM solutions. From database design and eCRF development to medical coding and accelerated database lock, we reduce queries by 60% while ensuring 100% data integrity. Platform-agnostic expertise across all major EDC systems delivers seamless, compliant study execution.
View Details
Biostatistics & Programming
Full-service biostatistics and CDISC programming from study design to submission. Expert teams deliver SAP, SDTM/ADaM and TFLs with double-programming QC. AI-enhanced workflows reduce timelines by 40% while maintaining 100% regulatory compliance.
View Details
Pharmacology & Modeling (PK/PD)
Accelerate drug development with advanced PK/PD modeling and AI-enhanced analytics. Comprehensive services from non compartmental analysis through population modeling to dosing optimization. IND to NDA support delivering regulatory-grade documentation for FDA/EMA/PMDA and more regulatory agencies.
View DetailsClinical Intelligence
Transforming complex data into actionable insights through AI-powered analytics to optimize trial oversight and decision-making.
Janus Visualization Dashboard
Real-time clinical trial monitoring with interactive dashboards. Track enrollment, safety signals, and data quality metrics at a glance. Customizable views enable sponsors and CRAs to make data-driven decisions faster with intuitive visualizations and automated alerts.
View Details
Clinical Data Processing Agent
AI-powered automation for routine data management tasks. Our intelligent agent handles medical coding suggestions, query generation, and data reconciliation, reducing manual effort by up to 60% while maintaining regulatory compliance and audit trails.
View Details
Customized AI Solutions
Tailored AI solutions for your unique clinical development challenges. From predictive analytics for patient recruitment to automated safety signal detection, we build custom models that integrate seamlessly with your existing workflows and systems.
View Details
Medical Affairs
Comprehensive medical affairs support from protocol development through post-marketing. Our team of MDs and medical writers ensures scientific accuracy, regulatory alignment, and clear communication across all clinical documentation and stakeholder interactions.
Medical Writing
Medical Monitoring
Medical Review
Safety Surveillance
Literature Review
Regulatory Document Support
Ready to accelerate your clinical program?
Accelerating Drug Development with Data-Driven Biometrics & Clinical Intelligence.
Accelerating Drug Development with Data-Driven Biometrics & Clinical Intelligence
Comprehensive clinical development from EDC to NDA/BLA approval. Our intelligence platform spans multiple therapeutic areas with real-time analytics. 15+ years, 1800+ studies, 50+ successful approvals delivering faster enrollment, minimal queries, and efficient regulatory pathways.
Service Highlights
End-to-end clinical solutions powered by AI and human expertise to ensure quality, efficiency, and faster patient access to care.
Quality
We never compromise on excellence.
Intelligence
We embrace technology to push boundaries.
Efficiency
We move quickly and deliver on time, every time.
Compassion
We care about the people behind every project.
Clinical AI Enablement Services
Core Competitive Advantages
Industry Experience Transformation
Valuable experience from 54 successful NDA/BLAs directly converted into AI training data, ensuring model professionalism and practicality.
Dual Expertise Integration
Deep integration of biostatistics and AI technology, understanding both business and technology, avoiding "AI for AI's sake" pitfalls.
Compliance-First Approach
All solutions comply with 21 CFR Part 11, GDPR, and other regulatory requirements, eliminating compliance risks for clients.
Mature Foundation
Existing AI Dashboard system and Agent development capabilities enable rapid deployment of new services, reducing implementation risks.
Flexible Deployment
Supporting cloud, on-premise, and hybrid deployment models to meet diverse client security and cost requirements.
Intelligent Clinical Data Labeling Services
An industry-leading data labeling system powered by 15+ years of clinical trial expertise and AI technology.
Annotation standards integrated from 1,800+ projects
Intelligent processing of AE classification, medical coding, and image annotation
Fully compliant with FDA/EMA data quality requirements
Results delivered in 3-6 months with minimal investment
Clinical Research Domain Knowledge Graph
A comprehensive knowledge network built on 50+ successfully approved NDA/BLA projects, covering disease–drug–gene–endpoint relationships.
Integrates historical trial data, regulatory requirements, and best practices
Intelligent decision support for protocol design, control group selection, and endpoint prediction
Second-level retrieval with deep industry insights
RLHF - Reinforcement Learning from Human Feedback
AI continuously refined by 200+ biostatisticians and data management experts, ensuring professional-grade outputs through real-world human feedback.
Expert judgment embedded into AI, such as SAP review, data review, clinical decision-making
Optimal human-AI collaboration in high-stakes, judgment-intensive tasks
Continuously iterated on real projects to meet the highest industry standards
RAG - Retrieval-Augmented Generation System
A clinical development-specific intelligent Q&A system built on ICH guidelines, FDA/EMA requirements, and 1,800+ historical trial datasets.
Instant, accurate support for regulatory consultation and requirement interpretation
Intelligent assistance for trial documentation preparation
Massive professional knowledge base with real-time update mechanism
Continuously iterated on real projects to ensure output quality
Clinical AI Workflow Automation
End-to-end process automation covering the complete chain from EDC data cleaning and quality checks to TFL generation.
Intelligent orchestration and task scheduling across clinical data workflows
Comprehensive efficiency gains of 60-80% in clinical data processing
Seamless integration into existing data pipelines
AI Skills Components & Tools Development
Modular, plug-and-play AI function libraries for rapid development of custom clinical decision support tools — powered by 6 patented technologies and a 50-member AI R&D team.
Ready-to-deploy AI components for specific clinical trial needs
Built on deep understanding of real-world clinical business scenarios
Designed for practicality and usability, not just technology showcase
Biometrics
Advanced biometrics integrating clinical intelligence with automation to deliver submission-ready data with precision and uncompromising integrity.
AI-Enhanced CDM
Clinical Data Management
Streamline your clinical data lifecycle with our AI-enhanced EDC&CDM solutions. From database design and eCRF development to medical coding and accelerated database lock, we reduce queries by 60% while ensuring 100% data integrity. Platform-agnostic expertise across all major EDC systems delivers seamless, compliant study execution.
Learn MoreAccelerated Data Insights
Biostatistics & Programming
Full-service biostatistics and CDISC programming from study design to submission. Expert teams deliver SAP, SDTM/ADaM and TFLs with double-programming QC. AI-enhanced workflows reduce timelines by 40% while maintaining 100% regulatory compliance.
Learn MoreAdvanced PK/PD Analytics
Pharmacology & Modeling (PK/PD)
Accelerate drug development with advanced PK/PD modeling and AI-enhanced analytics. Comprehensive services from non compartmental analysis through population modeling to dosing optimization. IND to NDA support delivering regulatory-grade documentation for FDA/EMA/PMDA and more regulatory agencies.
Learn More Innovation Spotlight
Clinical Intelligence
Transforming complex data into actionable insights through AI-powered analytics to optimize trial oversight and decision-making.
Real-Time Trial Insights
Janus Visualization Dashboard
Real-time clinical trial monitoring with interactive dashboards. Track enrollment, safety signals, and data quality metrics at a glance. Customizable views enable sponsors and CRAs to make data-driven decisions faster with intuitive visualizations and automated alerts.
Learn MoreIntelligent Data Automation
Clinical Data Processing Agent
AI-powered automation for routine data management tasks. Our intelligent agent handles medical coding suggestions, query generation, and data reconciliation, reducing manual effort by up to 60% while maintaining regulatory compliance and audit trails.
Learn MoreTailored AI Models
Customized AI Solutions
Tailored AI solutions for your unique clinical development challenges. From predictive analytics for patient recruitment to automated safety signal detection, we build custom models that integrate seamlessly with your existing workflows and systems.
Learn MoreMedical Affairs
Comprehensive medical affairs support from protocol development through post-marketing. Our team of MDs and medical writers ensures scientific accuracy, regulatory alignment, and clear communication across all clinical documentation and stakeholder interactions.
Medical Writing
Medical Monitoring
Medical Review
Safety Surveillance
Literature Review
Regulatory Document Support
Ready to accelerate your clinical program?
Accelerating Drug Development with Data-Driven Biometrics & Clinical Intelligence.
Submit RFP