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.
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.
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.
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.
Implementation and management of industry-leading EDC systems.
Custom configuration tailored to protocol requirements.
User training and ongoing support.
System validation that meets regulatory standards.
Centralized storage for standardized study data.
Cross-study visualization and analysis capabilities.
Metadata management to ensure data consistency.
CDISC-compliant data structures.
Automated ingestion from a variety of data sources.
Standardized mapping to CDISC formats.
Data transformation and reconciliation processes.
Maintenance of quality control and audit trails.
Real-time visualization of study metrics.
Dashboards for risk-based quality monitoring.
Tracking of enrollment and site performance.
Tools for assessing data quality.
