BIOSTATISTICS - DATA MANAGEMENT - EDC
The most efficient and cost-effective way to design and manage clinical trials is through EDC and clinical trial project management in one organization. We offer the advantage of one-stop for you to partner with clinical trial experts and biostatistics experts who have the ability to design, build, and manage your EDC System for small or large clinical trials.
BIOSTATISTICS
- Statistical Analysis Plans
- Interim and Final Analyses
- Randomization Schemes
- Sample Size Calculations
DATA MANAGEMENT
- Ensure 21 CFR 11 Compliance
- Database Development
- Data Entry
- Query Management
- Data Quality Audits
- Tables, Graphs
- Interim, Annual and Final Reports
EDC
- E-CRF design and development
- EDC Build
- Form Template Library
- Comprehensive Electronic Data Project Management
- Real-time data oversight
- Regulatory compliance: 21 CFR 11 with electronic signatures, complete audit trail
- Standard CDASH Form library
- Ability to create custom libraries for multiple studies for cost reduction
- Mid-study protocol amendment e-CRF changes