StudyLab
Intelligent Sample Management for Clinical Studies
Transform your bioanalytical laboratory with purpose-built lab digitization technology that streamlines sample workflows, ensures regulatory compliance, and accelerates study timelines.
Intelligent Sample Management for Clinical Studies
Transform your bioanalytical laboratory with purpose-built lab digitization technology that streamlines sample workflows, ensures regulatory compliance, and accelerates study timelines.
The Smartest Solution for Clinical Sample Processing
Sample-Life-Cycle Management
Comprehensive Sample Tracking: From sample manifest and receipt through storage, preparation, and analysis.
Intelligent Inventory Management: Real-time location tracking with automated storage condition monitoring.
Sample Preparation Workflow: SOP-guided processes with complete documentation and traceability.
Data Integrity Requirement: Full ALCOA+ compliance with attributable sample handling, documentationand and audit trails.
Assay Planning and Execution
Intelligent Assay Design: Various planning tools supporting LC-MS, LBA, and ADA methodologies.
Automated Plate Management: Standard plate design with sequence file generation and run optimization.
Reference Material Control: Complete management of standards, critical reagents, and preparation protocols.
Data Integrity Implementation: Immutable records of all assay parameters, electronic signatures for method approval, and validated data pathways.
Integrated Analytical Workflow
Direct Instrument Integration: Seamless connectivity with analytical instruments for automated data capture.
Real-Time Result Processing: Immediate import of raw data, chromatograms, and integrated results.
Intelligent Quality Control: Automated reassay evaluation and incurred sample reanalysis tracking.
360-Degree Study Insight: Complete data visibility across all study phases and analytical runs.
Report-Ready Data Management
ICH M10 Compliance: Preconfigured report templates meeting latest regulatory requirements.
CDISC SEND Export: Direct interface ensuring consistency between submission reports and regulatory standards.
Automated Report Generation: Instant creation of Analytical, Validation, ADA, and Immunogenicity reports.
Protected Data Integrity: Validated data transfer with safeguards against unintentional modifications.
Sample-Life-Cycle Management
Comprehensive Sample Tracking: From sample manifest and receipt through storage, preparation, and analysis.
Intelligent Inventory Management: Real-time location tracking with automated storage condition monitoring.
Sample Preparation Workflow: SOP-guided processes with complete documentation and traceability.
Data Integrity Requirement: Full ALCOA+ compliance with attributable sample handling, documentationand and audit trails.
Integrated Analytical Workflow
Direct Instrument Integration: Seamless connectivity with analytical instruments for automated data capture.
Real-Time Result Processing: Immediate import of raw data, chromatograms, and integrated results.
Intelligent Quality Control: Automated reassay evaluation and incurred sample reanalysis tracking.
360-Degree Study Insight: Complete data visibility across all study phases and analytical runs.
Assay Planning and Execution
Intelligent Assay Design: Various planning tools supporting LC-MS, LBA, and ADA methodologies.
Automated Plate Management: Standard plate design with sequence file generation and run optimization.
Reference Material Control: Complete management of standards, critical reagents, and preparation protocols.
Data Integrity Implementation: Immutable records of all assay parameters, electronic signatures for method approval, and validated data pathways.
Report-Ready Data Management
ICH M10 Compliance: Preconfigured report templates meeting latest regulatory requirements.
CDISC SEND Export: Direct interface ensuring consistency between submission reports and regulatory standards.
Automated Report Generation: Instant creation of Analytical, Validation, ADA, and Immunogenicity reports.
Protected Data Integrity: Validated data transfer with safeguards against unintentional modifications.
StudyLab for complex Bioanalytical Workflows
Sample-to-Report Workflow Automation
for any Bioanalytical Lab
Data Sources
Instrument Integration
Direct Analytical Instrument Connectivity and Data Capture
- Native interfaces for LC-MS, GC-MS, and analytical instrumentation.
- Real-time instrument performance monitoring and control.
- Automated calibration curve and quality control data capture.
File-Based Integration
Flexible File-based Data Exchange and Processing
- Automated processing of Excel, CSV, and proprietary data formats.
- Intelligent file monitoring and automated data extraction.
- Format standardization and validation for regulatory compliance.
Laboratory Applications Built-IN
Sample Management
Comprehensive
Sample Life-Cycle Tracking
- Complete sample chain of custody from receipt through disposal
- Intelligent storage management with condition monitoring and automated alerts
- Advanced sample preparation workflows with SOP integration and documentation
Method Management
Analytical Method Development, Validation and Control
- Comprehensive method library with version control and change management
- Reference material tracking and expiration management
- Assay planning tools with intelligent plate design and optimization
Report Management
Seamless Connection to Automated Document Generation
- Real-time data synchronization with report generation systems
- ICH M10 and FDA guidance-compliant report templates
- CDISC SEND export capabilities for regulatory submission consistency
From Sample Spread Sheets
to Study Intelligence
StudyLab within StudyGen 360
Laboratory Data Management
StudyLab represents a breakthrough in bioanalytical laboratory data management, specifically designed for the unique challenges faced by laboratories without comprehensive LIMS systems. As the first solution to capture entire data collection with a focused approach to reporting, StudyLab transforms traditional Excel-based, manual processes into automated, validated workflows that ensure complete data integrity and regulatory compliance.
StudyGen 360 Integration Advantage
Within the StudyGen 360 ecosystem, StudyLab seamlessly integrates with StudyReporter for automated report generation, StudyConnect for enhanced system connectivity, and StudyPlus for advanced analytics and long-term archiving. This integrated approach eliminates the need for copy-and-paste activities, reduces validation burden, and accelerates study completion while maintaining the highest standards of data integrity.
What this means for your Lab
Proven Performance
Built specifically for bioanalytical environments with deep understanding of laboratory workflows and challenges.
End-to-End Automation
Complete elimination of manual Excel-based data compilation and associated risks.
Regulatory Ready
Pre-validated cloud platform significantly reducing individual validation efforts.
Future-Proof Infrastructure
Scalable architecture supporting laboratory growth and evolving regulatory requirements.
Regulatory Confidence
Compliance is included in every Lab Process
Data Integrity Protection
Multi-layer controls preventing unauthorized data modifications.
21 CFR Part 11 Compliance
Complete electronic record management with validated electronic signatures.
GxP-Workflow Integration
Embedded regulatory requirements in standard operating procedures.
Immutable Audit Trails
Comprehensive tracking of all laboratory activities with tamper-evident documentation
Comprehensive tracking of all laboratory activities with tamper-evident documentation.
Change Control Integration
Systematic approval workflows for method modifications and process changes.
Validation Documentation
Automated generation of compliance documentation for regulatory inspections.
Your Journey Starts Here
Ready to elevate your lab processes to the next level?
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!
Your Journey Starts Here
Ready to elevate your lab processes to the next level?
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!