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

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

Intelligent Clinical Data Labeling Services

Leveraging our 15+ years of clinical trial experience, we have established an industry-leading data labeling system. By deeply integrating annotation standards from 1,800+ projects with AI technology, we enable intelligent processing of adverse event classification, medical coding, and image annotation tasks.

Unique Advantage: Our labeling services fully comply with FDA/EMA data quality requirements, deliver results within 3-6 months with minimal investment threshold, making it an ideal entry point for rapid data quality enhancement.

Clinical Research Domain Knowledge Graph

Clinical Research Domain Knowledge Graph

Based on 50+ successfully approved NDA/BLA projects, we have built a comprehensive knowledge network covering disease-drug-gene-clinical endpoint relationships. This graph integrates historical trial data, regulatory requirements, and best practices, providing intelligent decision support for protocol design, control group selection, and endpoint prediction.

Competitive Edge: Second-level retrieval capability combined with deep industry insights makes complex clinical decisions evidence-based.

RLHF - Reinforcement Learning from Human Feedback

RLHF - Reinforcement Learning from Human Feedback

Incorporating professional judgment from 200+ biostatisticians and data management experts into AI systems, continuously optimizing model performance through human feedback. Particularly in areas requiring professional judgment such as Statistical Analysis Plan (SAP) review and data review, achieving optimal human-AI collaboration.

Unique Feature: Continuous iteration based on real projects ensures AI outputs consistently meet the highest industry standards.

RAG - Retrieval-Augmented Generation System

RAG - Retrieval-Augmented Generation System

Integrating ICH guidelines, FDA Guidance, EMA requirements, and 1,800+ historical trial experience to build a clinical development-specific intelligent Q&A system. Provides instant, accurate support for regulatory consultation, trial documentation preparation, and regulatory requirement interpretation.

Competitive Strength: Combination of massive professional knowledge base with real-time update mechanism ensures information timeliness and accuracy.

Clinical AI Workflow Automation

Clinical AI Workflow Automation

End-to-end process automation solutions covering the complete chain from EDC data cleaning, quality checks to TLF generation. Through intelligent orchestration and task scheduling, achieving comprehensive efficiency gains in clinical data processing.

Value Proposition: While requiring longer investment cycles, it delivers 60-80% efficiency improvements, serving as critical infrastructure for digital transformation.

AI Skills Components & Tools Development

AI Skills Components & Tools Development

Providing modular, plug-and-play AI function libraries supporting rapid custom clinical decision support tool development. Based on 6 patent technologies and a 50-member AI team's R&D capabilities, offering innovative solutions for specific needs.

Differentiation: Deep understanding of clinical trial business scenarios ensures tool practicality and usability.

Biometrics

Advanced biometrics integrating clinical intelligence with automation to deliver submission-ready data with precision and uncompromising integrity.

Clinical Data Management

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.

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Biostatistics & Programming

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.

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Pharmacology & Modeling (PK/PD)

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.

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Clinical Intelligence

Transforming complex data into actionable insights through AI-powered analytics to optimize trial oversight and decision-making.

Janus Visualization Dashboard

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.

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Clinical Data Processing Agent

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.

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Customized AI Solutions

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.

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Medical Affairs

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

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Accelerating Drug Development with Data-Driven Biometrics & Clinical Intelligence.
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