Our integrated approach enables our experts to collaborate closely to deliver great value and a seamless experience for sponsors.
Our Data Management Services
- CRF Design and Development
- EDC Configuration
- Data Management Plan
- Data Validation Specification
- User Acceptance Testing
- Data integration Set-Up (e.g., IRT)
- External Data Management (data transfer agreement, data receipt, data validation and reconciliation, data integration)
- Clinical Data Review and Query Management
- Manual Listings Specification and Programming
- Clinical Data Coding (medDRA and WHOdrug)
- SAE Reconciliation
- EDC Training
- Lab Normal Ranges Handling
- Site and User Management
- Patient Profiles
- Interim and Final Database Lock
- CRF PDF Generation
- Blind Data Review Meeting
- Data Archival
Certified industry experts who can effectively guide the strategy, design, execution, standardization, and analysis of data, and help communicate the value of a new therapy.
Deep level of expertise, robust process, and unique data analytics capabilities.
Consistent high-quality data supporting streamlined timelines and successful submissions.