Understanding the Stakes:
Assay-Control Matters
In an increasingly complex regulatory environment, bioanalytical laboratories face growing challenges in maintaining consistent assay performance across long-running studies. Implementing standardized multi-run assay–controls and highlighted effective strategies for risk mitigation in bioanalytical testing is crucial.
Understanding the Stakes: Assay-Control Matters
In an increasingly complex regulatory environment, bioanalytical laboratories face growing challenges in maintaining consistent assay performance across long-running studies. Implementing standardized multi-run assay–controls and highlighted effective strategies for risk mitigation in bioanalytical testing is crucial.
Challenges We Address
Successful bioanalytical operations require proactive management and control of the most critical challenges in multi-run assay environments.
Compliance
Ensuring Data Integrity & Regulatory Excellence
- Maintain consistent data quality standards
- Ensure full GXP compliance
- Accelerate regulatory approvals
- Meet all acceptance criteria reliably
- Prepare confidently for inspections
Instrument Performance
Optimizing Operations & Capacity
- Prevent unexpected sample
re-runs - Maximize lab capacity utilization
- Maintain project timelines
- Control operational costs
- Optimize resource allocation
Quality Assurance
Strengthening Business Performance
- Build market reputation
- Protect financial performance
- Enhance sponsor relationships
- Strengthen competitive position
- Secure contract renewals
Standardized Assay Control Methods
Our comprehensive approach ensures consistency, reliability, and compliance across all assay runs.
Retention Time Control
- In-run consistency checks
- Cross-run variability analysis
- Drift detection algorithms
- Shift pattern recognition
Carryover Analysis
- Blank sample monitoring post-ULOQ
- Carryover trend identification
- Wash procedure effectiveness
- Maintenance scheduling alerts
Comprehensive tracking of all laboratory activities with tamper-evident documentation.
Internal Standard Control
- IS response variability tracking
- FDA Guidance 2019 compliance
- Automated flagging system
- Matrix effect detection
Instrument Performance
- System suitability testing
- Performance trend analysis
- Predictive maintenance alerts
- Equipment reliability scoring
With over two decades of specialized experience in bioanalytical data management, StudyGen 360 has established itself as the preferred quality control partner for leading bioanalytical laboratories worldwide. Our platform comprehensively designs solutions specifically for multi-run assay control and statistical quality management across complex bioanalytical studies.
Ready for Standardized Multi-Run Assay Control?
The next generation of assay control powered by AI and machine learning technologies.
Artificial Intelligence
Automated anomaly detection and predictive maintenance for your analytical instruments, reducing downtime and improving reliability.
Mobile Dashboards
Monitor critical parameters and receive instant alerts directly on your mobile device for immediate response.
Cloud Integration
Global access to assay data with real-time collaboration between sponsors and CROs across multiple locations.
Predictive Analytics
Anticipate assay problems before they occur with machine learning models trained on historical performance data.
Artificial Intelligence
Automated anomaly detection and predictive maintenance for your analytical instruments, reducing downtime and improving reliability.
Mobile Dashboards
Monitor critical parameters and receive instant alerts directly on your mobile device for immediate response.
Cloud Integration
Global access to assay data with real-time collaboration between sponsors and CROs across multiple locations.
Predictive Analytics
Anticipate assay problems before they occur with machine learning models trained on historical performance data.
Your Journey Starts Here
Ready for Standardized Multi-Run Assay Control?
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 for Standardized Multi-Run Assay Control?
Experience the power of StudyGen 360’s integrated platform.
In short:
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!