Database Design and CRF Development
Our team designs intuitive electronic Case Report Forms (eCRFs) that efficiently capture required data while minimizing site burden. We incorporate edit checks and validation rules to ensure data consistency and completeness, tailoring database structures to your specific protocol requirements while maintaining compliance with CDISC standards.
Data Capture Solutions
We implement and manage various data capture systems including EDC, ePRO/eCOA, and central lab integrations. Our platform-agnostic approach allows us to work with your preferred systems or recommend solutions that best fit your study needs, ensuring seamless data collection from multiple sources.
Data Validation and Cleaning
We execute comprehensive data validation procedures including programmed edit checks, manual reviews, and data reconciliation. Our query management process resolves discrepancies efficiently while maintaining detailed audit trails. We provide regular data quality metrics to track cleaning progress throughout your study.
Data Standards Implementation
We ensure all datasets comply with CDISC standards (SDTM, ADaM) required for regulatory submissions. Our standards experts stay current with evolving regulatory expectations to future-proof your data for seamless submissions to global health authorities.
Data Migration and Integration
We execute controlled migration of data between systems and integrate data from multiple sources including central labs, imaging, biomarkers, and wearable devices. Our integration strategies maintain data traceability while creating unified datasets for comprehensive analysis.
Database Lock Procedures
We manage systematic database closure with documented quality control reviews, ensuring all data is complete, clean, and query-free. Our lock procedures include comprehensive checklist verification and approval workflows that maintain data integrity while meeting your timeline requirements.
