Data is extracted from multiple sources such as Electronic Data Capture (EDC) systems and laboratory systems to ensure completeness and accuracy. A data warehouse or integrated platform is established for centralized storage and management.
Advanced analytics, including algorithms and artificial intelligence, are used to identify trends, outliers, and discrepancies in the data.
Data quality is evaluated, and key risk indicators along with quality risk tolerance thresholds are established.
We are committed to protecting subject rights and data integrity through a proactive, risk proportionate quality management strategy, supported by our self-developed system that provides visualized data aggregation and risk monitoring services.
Core functions include:
SRM –Systemic Risk Monitoring KDS – Key Data Surveillance MAD – Multivariate Anomaly Detection
SMT – Study Metrics Tracking
CMR – Comprehensive Medical Review
Supported Systems Include
1. A fully validated GCP-compliant ClinPlus RBQM system.
2. A customizable clinical data analysis and visualization platform.
Dedicated Centralized Monitoring Team
1. Possess comprehensive expertise in data management, statistical analysis, medical monitoring, operations, and data analytics.
2. Take full responsibility for the design and implementation of centralized monitoring services within the GCP ClinPlus RBQM framework.
3. Explore and integrate statistical modeling, data analysis, and AI technologies to develop innovative centralized monitoring methodologies.
4. Establish and continuously refine the knowledge system, methodology, and personnel training mechanisms for centralized monitoring.
5. Drive the development and integration of supporting digital systems and tools to ensure effective implementation of centralized monitoring.
Proactively identify risks, protect subject rights and data integrity, and lay a solid foundation for regulatory submissions.
Guide targeted verification through centralized analysis, reduce unnecessary efforts, and accelerate data cleaning and R&D processes.
Focus on critical risks, reduce on-site monitoring and error-correction costs, and achieve cost-effective efficiency.
Adhere to international standards, employ mature systems, and build a regulatory-trusted quality framework.
Leverage professional expertise and advanced technologies to continuously refine methodologies and empower trial operations.
GCP ClinPlus delivers exceptional expertise with genuine commitment to our projects. Their team demonstrates remarkable responsibility at every stage, consistently going above and beyond. In an industry where dedication matters, they've proven themselves an invaluable partner for our success.
After enrollment challenges with our previous CRO threatened our study timeline, GCP ClinPlus stepped in and transformed our project. Their team rapidly accelerated patient recruitment beyond our expectations and put our critical study back on track. Their clinical expertise and swift implementation proved decisive in securing our study's success.
GCP ClinPlus stands out for their exceptional responsiveness and customer focus. Their team consistently prioritizes our needs with prompt, thoughtful solutions to every challenge. Their combination of technical excellence and client-centered approach makes them a truly strategic partner in our development programs.
