StudyConnect
Smart Solutions for Laboratory Data Integration and Control
Transform heterogeneous lab environments into seamlessly connected, validated data ecosystems. StudyConnect bridges the gap between diverse laboratory systems, instruments, and data sources while ensuring data integrity and regulatory compliance.
Smart Solutions for Laboratory Data Integration and Control
Transform heterogeneous lab environments into seamlessly connected, validated data ecosystems. StudyConnect bridges the gap between diverse laboratory systems, instruments, and data sources while ensuring data integrity and regulatory compliance.
Break Data Silos accelerate Clinical Studies
Universal Lab Connectivity
Seamless LIMS Integration: Connect with any LIMS system
Direct Instrument Data Capture: Automated data collection from analytical instruments without manual intervention
Heterogeneous System Support: Bridge diverse laboratory systems (LIMS, ELN, SDMS, MS Excel, CDS, ERP/SAP, MES)
Data Integrity Requirement: All connections maintain ALCOA+ principles with complete data lineage and traceability from source to destination
Advanced Process Control
Study-Wide Data Consistency: Ensure uniform data quality across all study runs and analytical batches
Risk-Based Quality Management: Intelligent assessment and mitigation of data integrity risks
Workflow Standardization: Consistent processes regardless of underlying laboratory infrastructure.
Flexible Architecture
LIMS-Independent Operation: Full functionality for labs without dedicated LIMS systems
Cloud and On-Premise Deployment: Scalable architecture supporting diverse IT requirements
API-Driven Integration: Flexible connectivity supporting custom laboratory configurations
Legacy System Support: Seamless integration with existing laboratory infrastructure.
Regulatory Compliance
Real-time Data Analytics: Intelligent data analysis and trend monitoring
Automated Reporting: Generation of regulatory reports and study documentation
Dashboard and Visualization: Interactive dashboards for study managers and stakeholders
Audit Trail Management: Complete traceability of all data modifications
Regulatory Submission Support: Direct integration with regulatory authorities
Universal Lab Connectivity
Seamless LIMS Integration: Connect with any LIMS system
Direct Instrument Data Capture: Automated data collection from analytical instruments without manual intervention
Heterogeneous System Support: Bridge diverse laboratory systems (LIMS, ELN, SDMS, MS Excel, CDS, ERP/SAP, MES)
Data Integrity Requirement: All connections maintain ALCOA+ principles with complete data lineage and traceability from source to destination
Flexible Architecture
LIMS-Independent Operation: Full functionality for labs without dedicated LIMS systems
Cloud and On-Premise Deployment: Scalable architecture supporting diverse IT requirements
API-Driven Integration: Flexible connectivity supporting custom laboratory configurations
Legacy System Support: Seamless integration with existing laboratory infrastructure.
Advanced Process Control
Study-Wide Data Consistency: Ensure uniform data quality across all study runs and analytical batches
Risk-Based Quality Management: Intelligent assessment and mitigation of data integrity risks
Workflow Standardization: Consistent processes regardless of underlying laboratory infrastructure.
Regulatory Compliance
Real-time Data Analytics: Intelligent data analysis and trend monitoring
Automated Reporting: Generation of regulatory reports and study documentation
Dashboard and Visualization: Interactive dashboards for study managers and stakeholders
Audit Trail Management: Complete traceability of all data modifications
Regulatory Submission Support: Direct integration with regulatory authorities
Specific Integrations
LIMS Connectivity
Comprehensive LIMS Integration for
Lab Environments
- Direct connectivity to Watson LIMS, LabWare, LabVantage, and SAP-based systems.
- Automated study data extraction with complete metadata preservation.
- Real-time synchronization of analytical results and sample information.
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.
Master Your Lab Data Connectivity
Gold Standard Integration
GxP-compliant Connectivity Solutions
for all leading LIMS Platforms
Sciex
Waters
Agilent
MDS
MS-EXCEL
Watson LIMS™
Labware LIMS™
Sample Manager LIMS™
Labvantage LIMS™
further System on reuquest
Core Benefits
Connectivity
Universal integration capabilities supporting any lab infrastructure configuration with validated data pathways.
Control
Intelligent data validation and quality assurance ensuring consistent, reliable information across all connected systems.
Compliance
Built-in regulatory compliance features meeting FDA, EMA, and ICH requirements with comprehensive audit capabilities.
Consistency
Standardized data processing and validation rules ensuring uniform quality regardless of source system.
Confidence
Proven integration technology trusted by leading pharmaceutical and biotech companies worldwide.
Collaboration
Enhanced data visibility and accessibility supporting seamless teamwork across laboratory and regulatory functions.
Evolution of Excellence
From Sample Spread Sheets
to Study Intelligence
StudyConnect within StudyGen 360
Building on Proven Integration Excellence
StudyConnect represents the evolution of our market-leading laboratory integration capabilities (RemoteCollector), now enhanced within the comprehensive StudyGen 360 ecosystem. Trusted by 15 of the top 25 pharmaceutical and biotech leaders, our connectivity solutions have facilitated thousands of successful regulatory submissions through reliable, validated data integration.
StudyGen 360 Integration Advantage
As part of the StudyGen 360 platform, StudyConnect seamlessly integrates with StudyReporter for automated report generation, StudyLab for comprehensive sample and method management, and StudyPlus for advanced analytics and archiving. This integrated approach delivers unprecedented efficiency in laboratory data management while maintaining the highest standards of data integrity and regulatory compliance.
What this means for your Lab
Enhanced Capabilities
Access to the full StudyGen 360 ecosystem while maintaining specialized connectivity functionality.
Continued Excellence
Proven integration technology enhanced with platform-wide data integrity and workflow optimization.
Future-Ready Infrastructure
Seamless scalability with additional StudyGen 360 modules as your needs evolve.
Proven Track Record
Built on years of successful implementations across diverse laboratory environments.
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
Join leading research organizations using StudyConnect for seamless system and data integration. 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
Join leading research organizations using StudyConnect for seamless system and data integration. 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!