StudyGen 360
Gather information from different systems in one place, track results while the work is still running, and have reports ready when you need them.
StudyGen 360
Get Your Study in the Flow
Gather information from different systems in one place, track results while the work is still running, and have reports ready when you need them.
Study in FLOW
Information travels from the first import to the finished report along one connected path. Follow running studies in live views as work continues, and move data between tools with minimal manual effort.
Speed to RESULT
View and compare results in any study phase, in any format. Reports that once took days are generated in minutes, built on the lab’s own templates and automatically populated from study data. Report creation time falls by up to 70%, so findings reach the people who need them much sooner.
Compliance in FOCUS
Quality and regulatory requirements run through every data management process. Controls such as audit trails and eSignatures support 21 CFR Part 11, and the cloud platform is administered in a GxP-compliant manner.
StudyGen 360
Key Platform Features
Automated Reporting
Streamline study report generation while maintaining GxP compliance. Generate comprehensive, submission-ready study documentation in multiple formats with customizable templates, statistical analyses, and graphics - all automatically populated from your source systems without manual copy and paste.
Data Integration and Integrity
Centralize and harmonize data from multiple sources. Our Remote Collector technology seamlessly integrates with LIMS, ELN, CDS, ERP (SAP), MES, and other systems, enabling real-time data transfer while maintaining complete data integrity and traceability throughout the process.
Real-time Analytics
Follow results and identify trends as they emerge; create live tables at any time during your study. Live views and configurable analytics provide 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 workflows that scale with your organization's needs while reducing operational costs.
Automated Reporting
Streamline study report generation while maintaining GxP compliance. Generate comprehensive, submission-ready study documentation in multiple formats with customizable templates, statistical analyses, and graphics - all automatically populated from your source systems without manual copy and paste.
Real-time Analytics
Follow results and identify trends as they emerge; create live tables at any time during your study. Live views and configurable analytics provide 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 integrates with LIMS, ELN, CDS, ERP (SAP), MES, and other systems, enabling 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 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
- Sample lifecycle management, from receipt to storage
- Assay layouts and sequence files, sent to instruments
- Result import and automatic checks of each run
StudyReporter
Automated Reporting and Table Creation
- Generation of complex study reports and approval documents
- Configurable for any bioanalytical or stability study
- Word template-based document generation with protected data areas
StudyAI
AI-Powered Study Reporting
- Plain-language requests turned into configurations
- Layouts tried on anonymized seed data first
- Output reviewed by the lab against the source data
StudyInsight
Live Analytics Through Review and Monitoring
- Live views of results from studies still in progress
- Interactive dashboards and visualization tools
- Trend analysis spanning every run of the study
StudyPlus
Plus Features for Extended Demands
- Plus Archive: Long-term data archiving solutions
- Plus KPI: Key performance metrics and analytics
- Plus Exchange: Secure data exchange capabilities
- Template Designer: Custom report template creation
StudyConnect
Bringing Data Together From Any Source
- Direct integration with LIMS and laboratory systems
- File imports checked for format before acceptance
- Instrument data captured without manual re-entry
Data Management Platform for Clinical Studies
All StudyGen 360 applications in one booklet. Share it with your team and decision-makers.
The Future of Clinical Study Management
Every decision in a study rests on its data, and StudyGen 360 puts that data in one place, no matter what system it started in. Review results while the work is still running, and keep each value linked to its origin, so nobody waits for the final report to see where a study stands.
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 70%
• 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 and Collaboration
StudyGen 360 revolutionizes sponsor-CRO relationships through intelligent communication of study progress. While maintaining separate data environments, our platform enables unprecedented transparency in trial development.
100% Audit-Ready
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
Versioned electronic records, eSignatures, and role-based access support electronic records requirements.
Regulatory Guidance
Preconfigured tables and standardized formats follow ICH M10 and FDA guidance from the first report.
Faster Time to Market
Template-based reports replace manual creation, while automated QC reduces required cross-checks.
Statistical & Data Validation
Built-in statistical methods, 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.
Your Journey Starts Here
Ready to transform your clinical study 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 study 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!