StudyReporter
Smart Solutions for
Study Report Generation
Transform laboratory data into actionable insights with powerful reporting tools. StudyReporter streamlines the creation of standardized, regulatory-compliant reports while offering flexible visualization options. Quickly identify trends, anomalies, and critical outcomes across your study data, enabling faster decision-making and seamless knowledge sharing among the lab and stakeholders.
Smart Solutions for
Study Report Generation
Transform laboratory data into actionable insights with powerful reporting tools. StudyReporter streamlines the creation of standardized, regulatory-compliant reports while offering flexible visualization options. Quickly identify trends, anomalies, and critical outcomes across your study data, enabling faster decision-making and seamless knowledge sharing among the lab and stakeholders.
Delivering Measurable Results in time while reducing Operational Costs
Automated Data Processing
Eliminate manual data entry and reduce human error with our intelligent data processing algorithms that automatically validate, clean, and organize your clinical study data. Our wizard-guided setup processes ensure consistent data handling while maintaining complete transparency and traceability throughout the entire workflow. Built-in data integrity controls follow ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), ensuring every data point is fully traceable from source to final report.
Regulatory Compliance
Ensure GCP, FDA, and EMA compliance with built-in validation rules, audit trails, and standardized reporting formats that meet international regulatory requirements. Full 21 CFR Part 11 compliance ensures your submissions meet the highest regulatory standards with complete documentation integrity. Our comprehensive data integrity framework includes electronic signatures, timestamping, access controls, and immutable audit trails that demonstrate data reliability and trustworthiness throughout the entire study lifecycle.
Real-Time Reporting
Generate comprehensive reports instantly with real-time data synchronization. Monitor study progress, track enrollment, and identify trends as they happen. Create live tables at any time during your study, enabling proactive decision-making and immediate response to emerging data patterns.
Seamless Integration
Connect with existing EDC systems, CTMS platforms, and laboratory databases. Our flexible API ensures smooth data flow across your entire clinical research ecosystem. Direct integration with major LIMS systems including Thermo Scientific Watson LIMS, ELN, CDS, ERP (SAP), MES, and legacy systems.
Automated Data Processing
Eliminate manual data entry and reduce human error with our intelligent data processing algorithms that automatically validate, clean, and organize your clinical study data. Our wizard-guided setup processes ensure consistent data handling while maintaining complete transparency and traceability throughout the entire workflow. Built-in data integrity controls follow ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), ensuring every data point is fully traceable from source to final report.
Real-Time Reporting
Generate comprehensive reports instantly with real-time data synchronization. Monitor study progress, track enrollment, and identify trends as they happen. Create live tables at any time during your study, enabling proactive decision-making and immediate response to emerging data patterns.
Regulatory Compliance
Ensure GCP, FDA, and EMA compliance with built-in validation rules, audit trails, and standardized reporting formats that meet international regulatory requirements. Full 21 CFR Part 11 compliance ensures your submissions meet the highest regulatory standards with complete documentation integrity. Our comprehensive data integrity framework includes electronic signatures, timestamping, access controls, and immutable audit trails that demonstrate data reliability and trustworthiness throughout the entire study lifecycle.
Seamless Integration
Connect with existing EDC systems, CTMS platforms, and laboratory databases. Our flexible API ensures smooth data flow across your entire clinical research ecosystem. Direct integration with major LIMS systems including Thermo Scientific Watson LIMS, ELN, CDS, ERP (SAP), MES, and legacy systems.
Mature your Study Data Reporting
Automated Reports
at any time
from any source
in any format
for any use
Automated study data reporting offers transformative advantages by eliminating time-consuming manual processes while ensuring seamless integration across diverse data sources—from LIMS systems to direct Instrument or System Integration. Organizations benefit from unprecedented flexibility, generating reports in real-time or on schedule, in formats ranging from formal PDFs to live Reports, all tailored to specific needs, whether for regulatory compliance, internal monitoring, or strategic decision-making.
This comprehensive automation reduces report creation time by up to 70%, eliminates human errors, accelerates decision processes through timely insights, and significantly enhances stakeholder satisfaction through customized reporting solutions that adapt to evolving research requirements, ultimately enabling research teams to focus more on analysis and less on data compilation.
Key Features
Word Template-Based Generation
Customizable MS Word templates with protected data areas and integrity controls.
Predefined Statistical Evaluations
Built-in calculations for bioanalytics, stability, and immunoassays with validation checks.
Multi-Format Output
PDF/A documentation, CSV, and XML exports for further processing with complete data lineage.
Instant Report Generation
Complex documents created within minutes while maintaining full audit trail.
Data Integrity Controls
ALCOA+ compliant data handling with immutable audit trails and electronic signatures.
Validated Data Pathways
Every data transformation is validated, logged, and traceable from source to final report.
Data Sources
LIMS Connectivity
Comprehensive LIMS Integration for
Lab Environments
- Direct connectivity to Watson LIMS, LabWare, LabVantage, and SAP-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.
Regulatory Confidence
Full Compliance and Automation
at every Step
StudyReporter within StudyGen 360
Achieving Confidence Through Intelligent Automation
Organizations that seamlessly integrate compliance and data integrity into their entire workflow with intelligent automation will undoubtedly achieve regulatory confidence. By implementing automated systems that enforce regulatory compliance and data integrity principles at every stage of the process – from data capture to document creation – organizations can transform compliance from a tedious checkpoint into an embedded quality that flows naturally through all activities.
Measurable Impact: 50-70% Compliance Reduction with Zero Compromise
This comprehensive approach to data integrity and compliance leads to a significant reduction in the regulatory compliance burden (typically 50-70%), the near elimination of regulatory findings during inspections, and a substantial acceleration of submission timelines, shaving months off time to market. Beyond these operational efficiencies, regulatory automation with built-in data integrity provides organizations with the confidence to innovate boldly while maintaining unwavering compliance standards in an increasingly complex regulatory landscape.
Data Integrity & Compliance Features
Complete Audit Trails
Every action tracked and documented with immutable timestamps.
Version Control
Automated versioning eliminates manual reviews while preserving data lineage.
Data Integrity Protection
Protected data areas prevent unauthorized modifications with validation controls.
Human-Readable Documentation
No specialized software required for review, maintaining data accessibility.
Electronic Record Management
Full 21 CFR Part 11 compliance with electronic signatures and secure storage.
Change Control Workflows
Systematic approval processes ensure data modifications meet regulatory standards.
StudyReporter
Key Benefits
Introducing StudyGen 360 Reporter
A powerful transformation is here. iStudyReporter, trusted by 15 of the top 25 pharmaceutical and biotech leaders across the US and Europe, evolves into StudyGen 360 Reporter. This strategic advancement represents more than a name change – it’s a leap forward in digital study data management.
StudyGen 360 emerges as a comprehensive digital study data platform, engineered to meet the dynamic demands of modern pharmaceutical study management. Building on our legacy as the market leader in report writing solutions for Pharma, CRO, and Life Sciences, this platform marks a pivotal milestone in our mission to deliver cutting-edge digital data solutions.
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
Ready to elevate your clinical study reporting 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 clinical study reporting 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!