Clinical Data Management Services
Ensuring Data Quality from Collection to Submission
GCP ClinPlus delivers comprehensive clinical data management services designed to ensure the integrity, accuracy, and compliance of your trial data from protocol design through database lock. With 22 years of experience supporting over 2,200 successful projects and 160+ regulatory approvals, our data management team provides the foundation for successful clinical development.
Why Choose GCP ClinPlus for Data Management?
Quality-Focused Approach
● Standardized processes built on 22 years of experience
● Rigorous validation procedures to ensure data integrity
● Comprehensive quality control at every stage of data handling
● Meticulous documentation meeting global regulatory requirements
Regulatory Excellence
● 160+ NDA approvals from FDA, EMA, and NMPA
● CDISC compliance expertise across CDASH, SDTM, and ADaM standards
● Global regulatory knowledge from our experienced leadership team
● Audit-ready processes with proven inspection success
Integration with Biometrics
● Seamless coordination with biostatistics and programming teams
● Data structures optimized for efficient statistical analysis
● Unified data strategy across the clinical development lifecycle
● Streamlined workflows reducing time to database lock
Technology Expertise
● Leading EDC platforms implementation and management
● Integration capabilities for diverse data sources
● Automation tools for improved efficiency and quality
● Visualization solutions for real-time data oversight
Our Comprehensive Data Management Services
Study Setup and Configuration
● CRF/eCRF design and development optimized for data collection and CDISC compliance
● Database specification and build aligned with protocol requirements
● Edit check programming to ensure data quality at the point of entry
● Data validation plan development establishing quality control processes
Data Collection and Processing
● EDC system implementation and management on leading platforms
● External data integration from labs, ePRO, wearables, and other sources
● Query management and resolution with efficient workflows
● SAE reconciliation between clinical and safety databases
Medical Coding
● Standardized medical coding using MedDRA, WHO Drug, and other dictionaries
● Coding consistency across studies and programs
● Coding quality control with medical review
● Custom coding dictionaries for specialized therapeutic areas
Data Cleaning and Validation
● Systematic data cleaning processes to identify and resolve discrepancies
● Custom data validation checks beyond standard edit checks
● Risk-based approach focusing resources on critical data points
● Patient profile review for comprehensive data consistency
Database Lock and Archive
● Streamlined database lock procedures minimizing timeline delays
● Quality control metrics ensuring lock readiness
● Comprehensive documentation for regulatory submissions
● Compliant data archiving meeting long-term storage requirements
Specialized Data Management Solutions
Risk-Based Quality Management
Our risk-based approach to data management focuses resources where they matter most:
● Critical data identification aligned with study objectives
● Risk assessment and mitigation strategies tailored to your protocol
● Key risk indicators for proactive quality monitoring
● Targeted source data verification optimizing resources
Real-World Data Integration
We specialize in managing the unique challenges of real-world data sources:
● Electronic health record integration with clinical trial data
● Claims data processing for outcomes research
● Wearable and sensor data management for continuous monitoring
● Patient registry data standardization and analysis
Rescue Studies
Our experienced team can recover troubled studies with minimal disruption:
● Rapid assessment of current data state and quality issues
● Remediation planning with prioritized action items
● Data recovery and cleaning to salvage existing information
● Process improvements to prevent recurring issues
FSP Data Management
Our Functional Service Provider model offers flexible resourcing for your data management needs:
● Dedicated resources integrated with your team
● Scalable support adapting to changing trial volumes
● Knowledge continuity through consistent staffing
● Standard operating procedures ensuring consistent quality
Technology Solutions
GCP ClinPlus leverages leading technology platforms to optimize data management:
Electronic Data Capture (EDC)
● Implementation and management of industry-leading EDC systems
● Custom configuration aligned with protocol requirements
● User training and support
● System validation meeting regulatory requirements
Clinical Data Repository
● Centralized storage for standardized study data
● Cross-study visualization and analysis
● Metadata management ensuring consistency
● CDISC-compliant data structures
Data Integration Platform
● Automated ingestion from diverse data sources
● Standardized mapping to CDISC formats
● Data transformation and reconciliation
● Quality control and audit trail maintenance
Clinical Analytics
● Real-time visualization of study metrics
● Risk-based quality monitoring dashboards
● Enrollment and site performance tracking
● Data quality assessment tools
The GCP ClinPlus Data Management Advantage
Therapeutic Area Expertise
Our data management team brings specialized knowledge across diverse therapeutic areas:
● Oncology: Complex data collection for novel endpoints
● Gene Therapy: Specialized safety monitoring
● Rare Disease: Optimized data collection for limited populations
● Neurology: Cognitive assessment data handling
● Ophthalmology: Specialized imaging data management
● Cardiovascular: ECG and imaging data integration
Global Capability
Our global team structure provides comprehensive coverage:
● Follow-the-sun operations for accelerated timelines
● Local regulatory knowledge across major markets
● Multi-language capabilities for global studies
● Standardized processes ensuring consistent quality worldwide
Seamless Integration
We work as an extension of your clinical development team:
● Flexible engagement models from full service to FSP
● Technology bridging between your systems and ours
● Knowledge transfer ensuring operational continuity
● Collaborative approach to process development
Case Study: Optimized Data Management
A mid-sized biotech conducting multiple concurrent studies needed to optimize their data management approach while maintaining quality. By implementing GCP ClinPlus' data management services through a hybrid model, they achieved:
● 30% reduction in time to database lock
● 40% decrease in query volume through improved upfront processes
● Seamless integration with statistical programming and analysis
● Consistent data standards across their entire program
Commendation Letter
I want to express my thanks for the excellent coordination and data management support your team provided during our recent clinical studies. We were running three important projects at the same time, each with strict timelines, and your team handled every step with skill. From setting up the electronic case report forms (eCRFs) to locking the databases, every step was organized and timely. Your ability to bring together different data types—lab results, ePROs, and safety reports—into a single system made our processes far more efficient. The early validation work you performed helped us reduce queries and significantly reduced turnaround time. Thanks to your team’s efforts, we met all submission deadlines. Your reliability was key in helping us stay on track during a very difficult period. We’re truly grateful for your support.
Senior Clinical Data Manager, Global Pharma Company
Ready to Transform Your Clinical Data Management?
Contact us today for a complimentary assessment of your data management processes and discover how our experienced team can help streamline your clinical development.
Contact: Suling Zhang, VP of International Operations and Business Development
Email: suling.zhang@gcp-clinplus.com
Phone: 609-255-3581