Clinical Data Management
From Study Setup to Analysis-Ready Data
Structured data-management services designed to support accurate, consistent and analysis-ready clinical data.
Novastatix supports sponsors and CROs across the clinical data-management lifecycle, from study setup and data-collection design through data review, query management, external/vendor data reconciliation, safety reconciliation, database-lock readiness and final data delivery.
Services can be tailored to the sponsor's Electronic Data Capture (EDC) environment, Standard Operating Procedures (SOPs), study requirements and delivery model, either as an integrated work package or for selected data-management activities.
Study Setup & Database Design
Study setup, CRF/eCRF design and database configuration support.
- CRF/eCRF design and review
- EDC database build/configuration support
- Edit-check specification, programming and testing
- User Acceptance Testing (UAT) prior to database go-live
- CRF completion guidelines and data-entry conventions
- Integration specifications for external laboratory, ePRO and IRT/randomization data, where applicable
Data Review & Cleaning
Ongoing data review and cleaning aligned with study timelines.
- Ongoing manual and system-based data review
- Data-quality checks and discrepancy identification
- Review supporting protocol-deviation identification and safety-data consistency checks
- Data cleaning aligned with interim and final database-lock timelines
- Data-quality metrics and study-status reporting
Query Management
Query generation, tracking, follow-up and resolution documentation.
- Data-query generation, tracking and resolution
- Monitoring and follow-up of site responses
- Query-management conventions aligned with the Data Management Plan
- Query ageing, status and resolution metrics
- Documentation of query-resolution activities
External Data & Safety Reconciliation
External/vendor data and safety reconciliation support.
- Reconciliation of central/local laboratory and other external/vendor data
- ePRO and IRT/randomization data reconciliation, where applicable
- Serious Adverse Event (SAE) reconciliation between clinical and safety databases, where included in scope
- Reconciliation planning and specifications
- Discrepancy tracking, resolution and documentation
Database Lock & Data Delivery
Database-lock readiness, coordination and final cleaned-data delivery.
- Database-lock readiness assessment and checklist
- Review of outstanding queries and data-cleaning status
- Interim data cuts/freezes and final database-lock coordination
- Data extraction and transfer support
- Final cleaned-data delivery
- Post-lock changes and database unlock/re-lock support, where required
Data Management Planning, Oversight & Documentation
Data-management planning, sponsor oversight and study documentation.
- Data Management Plan (DMP) development and maintenance
- Study-specific data-management procedures aligned with sponsor SOPs
- Data-management oversight for CRO/vendor-managed activities, where applicable
- Study metrics and status reporting for sponsor oversight
- Data-management doc