StudyPlus
Your Smart Plus
for Advanced Analytics Archiving and Data Exchange
Transform study data into strategic business intelligence with comprehensive analytics, regulatory-compliant long-term archiving, and seamless data exchange capabilities.
Your Smart Plus for Advanced Analytics, Archiving and Data Exchange
Transform study data into strategic business intelligence with comprehensive analytics, regulatory-compliant long-term archiving, and seamless data exchange capabilities.
StudyPlus
Delivering measurable Results that maximize Data Value
Advanced Analytics and KPI Management
Comprehensive Performance Monitoring: Real-time KPI tracking across all study operations with customizable dashboards and automated reporting.
Intelligent Data Analytics: Advanced statistical analysis and trend identification supporting data-driven decision making.
Cross-Study Performance Assessment: Comparative analytics enabling optimization of laboratory operations and study outcomes.
DATA INTEGRITY REQUIREMENT: Complete ALCOA+ compliance with immutable analytics data, timestamped calculations, and comprehensive audit trails for all performance assessments and KPI evaluations.
Compliant Long-Term Archiving
Human-Readable Archive Generation: Complete study data archives in PDF/A format meeting FDA 21 CFR Part 11 requirements for inspection, review, and copying.
Comprehensive Data Preservation: Structured documentation viewable without specialized software, ensuring long-term accessibility and regulatory compliance.
Multi-Format Export Capabilities: Full set of supplemented CSV and XML files with exported study data for future analysis without tool dependencies.
DATA INTEGRITY REQUIREMENT: Immutable archival records with complete chain of custody, electronic signatures for archive approval, and validated long-term preservation meeting regulatory requirements.
Intelligent Data Platform
CDISC SEND Integration: Automated export interfaces ensuring consistency between submission reports and regulatory data standards.
Inter-Document Integrity: Systematic validation ensuring consistency across all study documents and data transfers.
Master Data Management: Integrated MDM functionalities overcoming data inconsistencies across multiple systems and sources.
Universal System Integration: Seamless connectivity with LIMS, ELN, SAP, SDMS, and legacy systems for comprehensive data exchange.
Strategic Business Intelligence
Repository-Based Analytics: Centralized data repository enabling advanced analytics and reporting across all study data.
Real-Time Data Synchronization: Synchronized and simultaneous access to current data from variety of sources in consistent, standardized formats.
Custom Reporting Integration: Support for standard reporting systems (Crystal Reports, InfoMaker) and platforms (SharePoint) with flexible customization.
Scalable Architecture: Enterprise-grade solutions supporting individual customization and scalability aligned with corporate IT environments.
Advanced Analytics and KPI Management
Comprehensive Performance Monitoring: Real-time KPI tracking across all study operations with customizable dashboards and automated reporting.
Intelligent Data Analytics: Advanced statistical analysis and trend identification supporting data-driven decision making.
Cross-Study Performance Assessment: Comparative analytics enabling optimization of laboratory operations and study outcomes.
DATA INTEGRITY REQUIREMENT: Complete ALCOA+ compliance with immutable analytics data, timestamped calculations, and comprehensive audit trails for all performance assessments and KPI evaluations.
Intelligent Data Platform
CDISC SEND Integration: Automated export interfaces ensuring consistency between submission reports and regulatory data standards.
Inter-Document Integrity: Systematic validation ensuring consistency across all study documents and data transfers.
Master Data Management: Integrated MDM functionalities overcoming data inconsistencies across multiple systems and sources.
Universal System Integration: Seamless connectivity with LIMS, ELN, SAP, SDMS, and legacy systems for comprehensive data exchange.
Compliant Long-Term Archiving
Human-Readable Archive Generation: Complete study data archives in PDF/A format meeting FDA 21 CFR Part 11 requirements for inspection, review, and copying.
Comprehensive Data Preservation: Structured documentation viewable without specialized software, ensuring long-term accessibility and regulatory compliance.
Multi-Format Export Capabilities: Full set of supplemented CSV and XML files with exported study data for future analysis without tool dependencies.
DATA INTEGRITY REQUIREMENT: Immutable archival records with complete chain of custody, electronic signatures for archive approval, and validated long-term preservation meeting regulatory requirements.
Strategic Business Intelligence
Repository-Based Analytics: Centralized data repository enabling advanced analytics and reporting across all study data.
Real-Time Data Synchronization: Synchronized and simultaneous access to current data from variety of sources in consistent, standardized formats.
Custom Reporting Integration: Support for standard reporting systems (Crystal Reports, InfoMaker) and platforms (SharePoint) with flexible customization.
Scalable Architecture: Enterprise-grade solutions supporting individual customization and scalability aligned with corporate IT environments.
Your Plus in StUdy Handling
Specific Data Management Applications
Long Term Archiving
StudyPlus Archive
Comprehensive regulatory-compliant archiving for bioanalytical and clinical studies
- Human-readable PDF/A format archives meeting FDA inspection requirements
- Complete CSV/XML data exports enabling future analysis without tool dependencies
- Integration with corporate document archiving solutions and CRO-sponsor data submission workflows
Performance Analytics
StudyPlus KPI
Advanced analytics and key performance indicator monitoring across all study operations
- Real-time performance dashboards with customizable KPI tracking and automated reporting
- Cross-study comparative analytics enabling operational optimization and strategic planning
- Advanced statistical analysis supporting evidence-based decision making and trend identification
Data Exchange
StudyPlus Exchange
Intelligent data exchange platform with comprehensive integration capabilities
- CDISC SEND export interfaces with automated validation and consistency checking
- Master Data Management resolving inconsistencies across multiple source systems
- Universal system integration supporting diverse IT environments and legacy systems
Business Intelligence
StudyPlus BI
Strategic data intelligence supporting pharmaceutical development decision-making
- Repository-based analytics with centralized data management and advanced reporting capabilities
- Real-time data synchronization from multiple sources with consistent formatting and validation
- Integration with standard reporting platforms and enterprise business intelligence systems
Core Benefits
Analytical
Advanced analytics and KPI monitoring transforming study data into strategic business intelligence with evidence-based decision support.
Archival
Regulatory-compliant long-term archiving with human-readable formats meeting FDA requirements and ensuring permanent data accessibility.
Accessible
Comprehensive data exchange capabilities enabling seamless integration across diverse systems and regulatory submission platforms.
Automated
Intelligent automation reducing manual processing by up to 90% while ensuring complete regulatory compliance and data integrity.
Comprehensive tracking of all laboratory activities with tamper-evident documentation.
Assured
Proven data management technology with comprehensive validation, regulatory expertise, and long-term support ensuring successful implementation.
Adaptable
Flexible architecture supporting diverse IT environments with scalable solutions meeting individual organizational requirements.
Advance
Your
Study Data Archiving
StudyPlus Archive offers transformative advantages by providing comprehensive long-term archiving solutions that ensure study data remains accessible and usable years after collection.
The system generates complete study documentation as flat files in directory structures including PDF/A, CSV, and XML formats, eliminating the need for Watson LIMS™ knowledge or additional applications. This comprehensive approach significantly enhances long-term research continuity while maintaining full regulatory compliance.
Long-Term Human-Readable Access at any Time
Eliminates System Dependencies
Access archived data without Watson LIMS™ knowledge or add. applications, ensuring long-term data accessibility regardless of system changes.
Flexible Data Organization
Archive information structured by experiment or any area of interest, supporting both regulatory compliance and ongoing research activities.
Accelerated Regulatory Processes
Readily available documentation speeds up regulatory submission processes and audit responses by providing instant access to study records.
Improved Operational Efficiency
Reduce data retrieval time by up to 80% and enhance research continuity through easily accessible and interpretable archived data.
It is no longer just about storing information for a specific period of time. Despite archiving, data should be easily and quickly accessible. Therefore, data archiving must be flexible, user-friendly and human-readable, while at the same time being audit-proof and capable of being integrated into the existing IT infrastructure.
StudyPlus Archive generates the complete study data documentation, as flat files in a directory structure such as PDF/A, CSV and XML. Thus, it is the perfect solution for long-term archiving of study data in human-readable formats.
StudyPlus Archive is designed for bioanalytical and clinical studies, including validation studies.
In Compliance with FDA Guidance für Industry: 21 CFR Part 11(11.10(b) and 11.50).
ALCOA+ Compliance for your plus on Data Management
Advanced Data Management Controls
StudyPlus within StudyGen 360
Advanced Data Management Innovation
As the strategic intelligence layer of the StudyGen 360 ecosystem, StudyPlus transforms raw study data into actionable business intelligence while ensuring complete regulatory compliance and long-term data accessibility.
Addressing Critical Industry Requirements
StudyPlus specifically addresses the FDA requirement for long-term availability of electronic data in human-readable form for audit purposes. While established CDISC standards do not cover all relevant bioanalytical data, particularly from validation studies, StudyPlus provides comprehensive solutions ensuring regulatory compliance while maximizing the strategic value of study data investments.
StudyGen 360 Integration Advantage
Within the StudyGen 360 ecosystem, StudyPlus seamlessly integrates with StudyReporter for comprehensive reporting analytics, StudyLab for laboratory performance monitoring, StudyConnect for enhanced data integration, and StudyInsight for quality oversight intelligence. This integrated approach provides unprecedented visibility into study performance and supports informed descison making.
What this means for Pharmaceutical Development
Strategic Intelligence
Transform study data investments into actionable business intelligence supporting evidence-based decision making.
Regulatory Assurance
Complete FDA 21 CFR Part 11 compliance with human-readable archival meeting all inspection requirements.
Operational Efficiency
Up to 90% reduction in manual archival and data exchange processes through intelligent automation.
Future-Proof Data Management
Permanent data accessibility without software dependencies ensuring long-term value preservation.
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
Streamline Your Operations with integrated Data Archive and KPI Analysis. 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
Streamline Your Operations with integrated Data Archive and KPI Analysis. 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!