Clinical Data Management is the foundation of reliable clinical research outcomes. Clinovalife delivers structured, technology-driven, and regulator-ready data management solutions that ensure data integrity, compliance, and submission readiness across all phases of clinical development (Phase I–IV).
Clinovalife operates through a risk-based, quality-centric framework aligned with ICH-GCP, FDA, EMA, PMDA and global regulatory expectations.
Study Start-Up & Planning
Data Management Strategy Development
- Development of Data Management Plan (DMP)
- Risk-based data review strategy
- Data flow documentation and oversight
- Vendor data integration planning
CRF Design & CDASH Alignment
- CRF design and optimization aligned with CDASH standards
- eCRF review and sponsor collaboration
- Metadata-driven CRF libraries
- Cross-study harmonization strategy
Database Build & Configuration
- EDC database setup and configuration
- Edit check specifications and programming
- User Acceptance Testing (UAT) coordination
- Role-based access configuration
- Integration of external data streams
Data Collection & Processing
Data Review & Cleaning
- Real-time data validation
- Manual and automated discrepancy detection
- Query management and tracking
- Risk-based central data review
Medical Coding
- MedDRA coding for adverse events
- WHODrug coding for concomitant medications
- Coding review and reconciliation
External Data Reconciliation
- Central lab data reconciliation
- ECG / Imaging / PK data reconciliation
- Vendor data integration validation
- SAE reconciliation with pharmacovigilance
Data Quality & Compliance Oversight
Quality Control & Validation
- Data validation plan execution
- Quality control review of critical variables
- Audit trail review and documentation
- Compliance monitoring
Risk-Based Data Monitoring
- Central statistical monitoring
- Key Risk Indicator (KRI) tracking
- Data trend analysis
- Cross-site consistency checks
Regulatory Inspection Readiness
- Documentation preparation
- TMF data documentation support
- Inspection response support
- Data traceability verification
Database Lock & Study Close-Out
- Final data cleaning and query resolution
- Pre-lock quality review
- Database freeze and lock management
- Data archival
- Data transfer to biostatistics and programming teams
- Submission-ready dataset validation
Technology & Innovation
- EDC platforms (Medidata, Oracle, Veeva, etc.)
- Metadata-driven systems (e.g., Oracle DMW)
- Automated validation checks
- AI-assisted anomaly detection
- Real-time dashboard reporting
- Integration with CDISC standards
Our CDM Value Proposition
- CDASH-aligned CRF optimization
- Metadata-driven database architecture
- Integrated SAE reconciliation processes
- Risk-based central monitoring
- Full regulatory inspection readiness
- Seamless integration with SDTM & ADaM programming