StudyGen 360
Collect and recognize data from multiple sources for various purposes. Get insights and automated reports on compliant study data at any time during the study.
StudyGen 360
Get Your Study in the Flow
Collect and recognize data from multiple sources for various purposes. Get insights and automated reports on compliant study data at any time during the study.
Study in FLOW
Context-related analysis and dynamic interpretation transform study results into active clinical knowledge that drives quality and therapeutic innovation. Our integrated approach ensures your data moves seamlessly from collection through analysis to actionable insights, eliminating bottlenecks that slow down critical research timelines.
Speed to RESULT
From clinical data to actionable results. View and compare results in any study phase in any format. Our automated reporting capabilities generate complex approval documents within minutes, reducing time-to-market for life-saving therapies while maintaining the highest standards of accuracy and compliance.
Compliance ASSURED
Meeting and exceeding regulatory requirements in clinical study data handling. Quality and compliance in every data management process. Built-in 21 CFR Part 11 compliance, complete audit trails, and validated workflows ensure your submissions meet global regulatory standards without compromise.
StudyGen 360
Key Platform Features
Automated Reporting
Streamline study report generation while maintaining GxP compliance. Generate comprehensive, human-readable study documentation in PDF/A format with customizable templates, statistical analyses, and graphics - all automatically populated from your source systems without manual intervention.
Data Integration and Integrity
Centralize and harmonize data from multiple sources. Our Remote Collector technology seamlessly connects to LIMS, ELN, CDS, ERP (SAP), MES, and other systems, providing real-time data transfer while maintaining complete data integrity and traceability throughout the process.
Real-time Analytics
Monitor study progress and identify trends as they emerge, create Live tables at any time of your study. Dynamic dashboards and configurable analytics provide instant visibility into study performance, enabling proactive decision-making and risk mitigation.
Digitization of Lab Processes
Move from standard tools to innovative lab solutions, where Excel limits end and efficiency begins. Transform manual, error-prone processes into automated, validated workflows that scale with your organization's needs while reducing operational costs.
Automated Reporting
Streamline study report generation while maintaining GxP compliance. Generate comprehensive, human-readable study documentation in PDF/A format with customizable templates, statistical analyses, and graphics - all automatically populated from your source systems without manual intervention.
Real-time Analytics
Monitor study progress and identify trends as they emerge, create Live tables at any time of your study. Dynamic dashboards and configurable analytics provide instant visibility into study performance, enabling proactive decision-making and risk mitigation.
Data Integration and Integrity
Centralize and harmonize data from multiple sources. Our Remote Collector technology seamlessly connects to LIMS, ELN, CDS, ERP (SAP), MES, and other systems, providing real-time data transfer while maintaining complete data integrity and traceability throughout the process.
Digitization of Lab Processes
Move from standard tools to innovative lab solutions, where Excel limits end and efficiency begins. Transform manual, error-prone processes into automated, validated workflows that scale with your organization's needs while reducing operational costs.
Modular Ecosystem for complete Lab Data processing
StudyGen 360's modular architecture adapts to your specific needs with seamless integration across all components
StudyGen 360 Applications in Detail
StudyLab
Digitization of Lab Processes
- Lab Samples: Complete sample
lifecycle management - Lab Methods: Standardized method validation and execution
- Lab Results: Integrated results processing and analysis
StudyReporter
Automated Reporting and Table Creation
- Generation of complex study reports and approval documents
- Bioanalytic, Stability, DTA, and Immunoassay specialized modules
- Word template-based document generation with protected data areas
- Guided setup for efficient document creation
StudyAI
AI-Powered Clinical Research Data Management
- AI integration in clinical study evaluation accelerates data analysis
- Independently handles data validation, regulatory reporting, and safety monitoring
- Seamlessly works across all StudyGen 360 products
StudyInsight
Real-time Analytics Through Review and Monitoring Features
- Real-time study monitoring and oversight
- Interactive dashboards and visualization tools
- Trend analysis and predictive insights
StudyPlus
Plus-Features For Extended Demands
- Plus Archive: Long-term data archiving solutions
- Plus KPI: Performance metrics and analytics
- Plus Exchange: Secure data exchange capabilities
- Template Designer: Custom report template creation
StudyConnect
Data Integration From Any Source
- Connect LIMS: Direct integration with laboratory systems
- Connect Files: Secure file transfer and management
- Connect Instruments: Real-time instrument data collection
The Future of Clinical Study Management
In today's innovative research environment, your study data is more than just numbers – it's your competitive edge. StudyGen 360 ensures every data point drives value, combining seamless collection, intelligent management, and strategic evaluation.
Proven Track Record
Developed in partnership with leading international pharmaceutical companies, StudyGen 360 has been trusted by organizations worldwide to:
• Reduce approval document creation time by up to 95%
• Eliminate manual data entry errors
• Accelerate time-to-market for critical therapies
• Ensure 100% regulatory compliance
• Integrate seamlessly with existing IT infrastructure
Whether you're running preclinical trials, managing clinical studies, or conducting stability tests - StudyReporter delivers GxP-compliant automated reporting across pharmaceutical, biotech, and CRO environments. Experience seamless data collaboration that turns complex multi-source data into polished submission documents at unprecedented speed.
Bridging Sponsors and CROs
Enhanced Transparency & Collaboration
StudyGen 360 revolutionizes sponsor-CRO relationships through intelligent study progress communication. While maintaining separate data environments, our platform enables unprecedented transparency in trial development.
Built-In Compliance Across Every Function
Built-In Compliance Across Every Function
GxP Data Integrity
End-to-end data integrity controls with ALCOA+ principles embedded across all StudyGen 360 modules for preclinical, clinical, and stability studies.
21 CFR Part 11 Electronic Records
Complete electronic signature workflows with secure user authentication and validation across all study data management processes.
ICH & Regulatory Readiness
Pre-configured workflows meeting ICH guidelines for clinical study data management with automated validation reporting capabilities.
Faster Time to Market
Reduced workload through automated, template-based report generation without time-consuming, manual creation processes or data revalidation (QC checks).
Statistical & Data Validation
Built-in statistical methods with regulatory acceptance criteria and automated outlier detection for all study types and phases.
Global Regulatory Standards
Multi-region support for FDA, EMA, PMDA and other international regulatory requirements with localized submission templates.
Relevant Industries
Large AND Small Molecules
Advanced reporting for PK/PD studies, method validation, and bioequivalence trials. Automated generation of calibration curves, dilution summaries, and statistical analyses with built-in validation checks.
Multi-Run Assay Control
Multi-run QC management with automated trend analysis, statistical process control, and real-time monitoring. Intelligent assay drift detection, outlier assessment, and run-to-run comparability with regulatory-compliant documentation.
Immunogenicity
Comprehensive immunogenicity evaluation tools with automated ADA screening, confirmatory assays, and neutralizing antibody assessments. Statistical evaluations tailored to regulatory requirements.
Stability
Dedicated stability testing workflows with automated trend analysis, shelf-life predictions, and regulatory-compliant stability reports. Real-time monitoring of critical quality parameters.
Your Journey Starts Here
Ready to transform your clinical trials data management?
Experience the power of StudyGen 360's integrated platform.
Scalable Solution for Any Lab Size
Whether you're a small research lab or a large pharmaceutical company, StudyGen 360 scales with your needs. Read our success story!
Your Journey Starts Here
Ready to transform your clinical trials data management?
Experience the power of StudyGen 360's integrated platform.
Scalable Solution for Any Lab Size
Whether you're a small research lab or a large pharmaceutical company, StudyGen 360 scales with your needs. Learn more here!