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.
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.
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: Sample location tracking with user-defined storage condition recording.
Sample Preparation Workflow: SOP reference recorded per run for traceability.
Data Integrity Requirement: Supports ALCOA+ requirements with user-attributed records, timestamped entries, and immutable audit trails.
Assay Planning and Execution
Intelligent Assay Design: Run planning with plate layout and injection sequence builders for LBA and LC-MS assays.
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: Assay template parameters locked on activation, with user-attributed approval workflow and audit trail designed to support computer system validation.
Integrated Analytical Workflow
Direct Instrument Integration: Seamless connectivity with analytical instruments for automated data capture.
Real-Time Result Processing: Import of instrument-reported results with automatic matching to run layout positions.
Intelligent Quality Control: Automated reassay evaluation and tracking of incurred sample reanalysis.
360-Degree Study Insight: Complete data visibility across all study phases and analytical runs.
Regulatory Compliance
21 CFR Part 11 Support: User-attributed approval workflows and validated electronic signatures for complete electronic record management.
Immutable Audit Trails: Tamper-evident tracking of all laboratory activities, from sample receipt to final result.
Change Control Integration: Versioned assay templates with a complete audit trail.
Validation Documentation: Pre-validated system with validation documentation available upon request.
Sample-Life-Cycle Management
Comprehensive Sample Tracking: From sample manifest and receipt through storage, preparation, and analysis.
Intelligent Inventory Management: Sample location tracking with user-defined storage condition recording.
Sample Preparation Workflow: SOP reference recorded per run for traceability.
Data Integrity Requirement: Supports ALCOA+ requirements with user-attributed records, timestamped entries, and immutable audit trails.
Integrated Analytical Workflow
Direct Instrument Integration: Seamless connectivity with analytical instruments for automated data capture.
Real-Time Result Processing: Import of instrument-reported results with automatic matching to run layout positions.
Intelligent Quality Control: Automated reassay evaluation and tracking of incurred sample reanalysis.
360-Degree Study Insight: Complete data visibility across all study phases and analytical runs.
Assay Planning and Execution
Intelligent Assay Design: Run planning with plate layout and injection sequence builders for LBA and LC-MS assays.
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: Assay template parameters locked on activation, with user-attributed approval workflow and audit trail designed to support computer system validation.
Regulatory-Ready Compliance
21 CFR Part 11 Support: User-attributed approval workflows and validated electronic signatures for complete electronic record management.
Immutable Audit Trails: Tamper-evident tracking of all laboratory activities, from sample receipt to final result.
Change Control Integration: Versioned assay templates with a complete audit trail.
Validation Documentation: Pre-validated system with validation documentation available upon request.
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
- Run layouts and sequence files sent directly to the instrument
- Connects LC-MS and LBA instruments by interface or file import
- Calibration curves and QC results evaluated automatically
File-Based Integration
Flexible File-Based Data Exchange
and Processing
- Automated processing of Excel, CSV, and proprietary data formats.
- Structured file intake with automatic data extraction and run matching.
- Imported data mapped to run layout with format checks before acceptance
Laboratory Applications Built-In
Sample Management
Comprehensive
Sample Life-Cycle Tracking
- Complete sample chain of custody from receipt through disposal
- Storage and location management, with every transfer and freeze-thaw cycle recorded
- Sample preparation support, with every dilution and aliquot linked back to its parent sample
Method Management
Analytical Method Development, Validation, and Control
- Comprehensive method library with version control and change management
- Record lot numbers and expiry dates for critical reagents and reference materials during run preparation.
- 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
Sample Lifecycle Coverage
From sample planning to freeze-thaw cycles, StudyLab documents each step automatically – giving you a traceable, GLP-ready audit trail without manual logs.
Pre-Arrival — Sample Manifest
– Sponsor manifests uploaded in the system
– Sample mapping configured to your design
– Sample IDs and metadata in place before intake
– Single source of truth from day one
Receiving — Shipment Arrival
– Arrival, sender, and documents on receipt
– Internal barcode assignment
– Containers assigned to a defined storage
– Received samples linked to the sample plan
Receiving — Physical Samples
– Every sample registered and linked
– Parent-child tracking across aliquots
– Status and location visible per aliquot
– Full chain of custody from arrival onwards
Storage — Locations
– Room, freezer, and container on receipt
– Individual hierarchical storage structure
– Storage temperature held per location
– Current location visible on sample records
Stability — Freeze-Thaw Cycles
– Every retrieval + return auto-logged
– Thaw cycles counted per sample
– Duration at each location calculated
– Stability claims traceable to the aliquot
Preparation — Aliquoting
– Split, dilute, and relocate samples in a step
– Child barcodes auto-assigned from parent
– Dilution factor carried with every aliquot
– Corrections to parent to all children
From Sample Spreadsheets
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 a solution for capturing entire data collection with a focused approach to reporting, StudyLab transforms traditional Excel-based, manual processes into structured digital workflows designed to support data integrity and regulatory compliance requirements.
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 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 a deep understanding of laboratory workflows and challenges.
End-to-End Automation
Significantly reduces manual Excel-based data handling.
Regulatory Ready
A pre-validated cloud platform significantly reduces individual validation efforts.
Future-Proof Infrastructure
A scalable architecture supports laboratory growth and evolving regulatory requirements.
Regulatory Confidence
Built Around GxP and Data Integrity Principles
Data Integrity Protection
Role-based access and protected results tables, preventing unauthorized or unintended changes to data.
21 CFR Part 11 Compliance
Versioned electronic records, audit trails, and eSignatures, keeping every item traceable to its origin.
GxP-Compliant Administration
Cloud platform administered in a GxP-compliant manner, with StudyLab documenting each sample’s chain of custody.
Immutable Audit Trails
Every user action is recorded with who, what, and when, and hashing makes archive changes detectable.
Comprehensive tracking of all laboratory activities with tamper-evident documentation.
Traceable Changes
Versioned assay templates with a complete audit trail.
Validation Support
Documentation and support for each lab’s own validation effort, significantly reducing the work required.
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!