eTMF Management
Digital precision and audit readiness for your trial master files.
Our eTMF services utilize the DIA Reference Model to ensure your trial documentation is complete, contemporary, and compliant, ensuring inspection readiness at all times.
- DIA Model Alignment: Compliance with the latest TMF Reference Model standards.
- Quality Management: Systematic QC checks for document clarity and GCP compliance.
- Real-time Readiness: Dashboard-driven tracking of document health.
Clinical Data Management
Ensuring end-to-end clinical data integrity and analysis readiness.
From database build to final lock, our data management specialists ensure your trial data is clean, consistent, and ready for statistical analysis according to CDISC standards.
- Query Resolution: Rapid identification and closing of data discrepancies.
- Database Validation: Build and validation of study-specific clinical databases.
- SDV Support: Rigorous Source Data Verification and safety reconciliation.